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Feb. 27, 2010
Mithaighar Sweetened Yoghurt Recalled
Euroversal International/Mithaighar has recalled all of its Mithaighar Sweetened Yoghurt,
because it was produced on premises that were served with a Hygiene Emergency Prohibition
Order and a Remedial Action Notice by the local authority for that area because of poor food
hygiene.
The Agency has issued a Food Alert for Information.
Euroversal International/Mithaighar has recalled the product and will display point-of-sale
notices in shops that sell the yoghurt, explaining to customers why the product has been
recalled and advising that customers shouldn't eat the yoghurt and should return it to the
shop.
The recalled product is:
- Mithaighar Sweetened Yoghurt (Doi)
All 'use by' dates up to and including 7 March 2010
Pack size: Small, medium, large
No other Euroversal International/Mithaighar products are known to be affected.
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Feb. 27, 2010
Pro-Pak Foods Recalls Some Sliced Chicken Roll
Pro-Pak Foods has recalled some of its two sliced chicken roll products, because they are
contaminated with listeria. The products are Country Store Chicken Roll and Netto Chicken
Roll. Listeria is a bacterium that causes food poisoning. The Agency has issued a Food Alert
for Information.
Pro-Pak Foods has carried out a product recall and will be displaying point-of sale-notices
in shops that sell either of the products, explaining to customers why the products have
been recalled. If you have bought an affected product you can get a full refund.
The products are distributed in:
But not Northern Ireland
The recalled products are:
- Country Store Chicken Roll
Pack size: 125g
'Use by' dates: 28 February 2010, 2 March 2010, 7 March 2010, 8 March 2010, 9 March 2010 and
14 March 2010
- Netto Chicken Roll
Pack size: 400g
'Use by' dates: 27 February 2010, 4 March 2010, 6 March 2010, 7 March 2010, 9 March 2010, 12
March 2010
No other Pro-Pak Foods products are known to be affected.
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Feb. 27, 2010
Johnny's French Dip Powdered Au Jus Recalled
Tacoma, WA - Johnny's Fine Foods of Tacoma, Wash., Johnny's Fine Foods is recalling French
Dip Powdered Au Jus in 6oz bottles and French Dip Powdered Au Jus in 1.1oz foil packets,
because it has the potential to be contaminated with Salmonella. Salmonella is an organism
which can cause serious and sometimes fatal infections in young children, frail or elderly
people, and others with weakened immune systems. Healthy persons infected with Salmonella
often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
In rare circumstances, infection with Salmonella can result in the organism getting into the
bloodstream and producing more severe illnesses such as arterial infections (i.e., infected
aneurysms), endocarditis and arthritis.
To date no known illnesses have been associated with this product.
Johnny's French Dip Powdered Au Jus is distributed nationwide and is sold in retail stores.
- Johnny's French Dip Powdered Au Jus 6oz is packaged in a clear plastic bottle with a
red, white and blue label. The expiration date for this product is 0332. Johnny's French Dip
Powdered Au Jus 1.1oz is packaged in a red, white and blue foil packet. The expiration date
for this product is 02212.
The product was made using hydrolyzed vegetable protein manufactured by Basic Food Flavors,
Inc. Las Vegas, Nevada. Basic Food Flavors initiated a recall of the hydrolyzed vegetable
protein due to Salmonella contamination.
This product should be destroyed immediately. Consumers with questions may contact Johnny's
Fine Foods at 1-800-962-1462 Monday thru Friday 8am to 3pm Pacific Standard Time.
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Feb. 27, 2010
American Pecan Co. Recalls Pecans
American Pecan Co. of Yancey, Texas, is recalling 1 lb. bags of Pecan Pieces, small, medium,
and large sizes, because they have the potential to be contaminated with Salmonella, an
organism which can cause serious and sometimes fatal infections in young children, frail or
elderly people, and others with weakened immune systems. Healthy persons infected with
Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and
abdominal pain. In rare circumstances, infection with Salmonella can result in the organism
getting into the bloodstream and producing more severe illnesses such as arterial infections
(i.e., infected aneurysms), endocarditis and arthritis.
The 1 lb. bags of pecans were sold to walk-up customers at
- their Yancey, Texas location
- as well as to mail order customers in
- Texas
- New York
- Massachusetts
The bagged pecans consist of Ziploc-type bags labeled with "PECAN PIECES (Small, Medium, or
Large) Ingredients: Shelled Pecans: Repacked by: American Pecan Co. P.O. Box 151 Yancey, Tx.
78886 Net weight 1-Lb. (16 oz.) 454 g. Might contain Pecan shells.." There are no codes
associated with the products. No illnesses have been reported to date.
The recall was as the result of a routine sampling by the Food and Drug Administration,
which revealed that the finished products contained the bacteria. The company has ceased the
production and distribution of the product as FDA and the company continue their
investigation as to what caused the problem.
Consumers who have purchased 1 lb. bags of PECAN PIECES are urged to dispose of the products
and contact Mr. Rey Elizondo at American Pecan Co. for further instructions at
1-800-364-9053. Mr. Elizondo will be available 9:00 A.M. to 5:00 P.M., CST, Monday thru
Friday.
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Feb. 26, 2010
Thumb Oilseed Recalls Soy Grits and Flour
Thumb Oilseed Producers' Cooperative of Ubly, MI. has recalled certain shipments of
soybean grits and flour because they have the potential to be contaminated with
Salmonella, an organism which can cause serious and sometimes fatal infections in young c
hildren, frail or elderly people, and others with weakened immune systems. Healthy
persons infected with Salmonella often experience fever, diarrhea (which may be bloody),
nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can
result in the organism getting into the bloodstream and producing more severe illnesses.
No illnesses have been reported to date.
The recalled soybean grits and flour were distributed to a limited group of wholesale
customers located around the nation. These customers have been contacted by Thumb Oilseed
and are reviewing this inventories and production processes and taking the necessary
steps to protect consumer health, including, if necessary, sub recalls.
The product is labeled with Soy Beginnings or Nexsoy brands; packaged in 40# paper bags.
Feed is packaged in 1500# totes. (Lot numbers include TF121608 through TF012210, TG121608
through TG010510).
The recall resulted from routine sampling programs conducted by the company and its
wholesale customers. Thumb Oilseed has suspended production and distribution of the
potential affected products and is cooperating with the US Food and Drug Administration
and Michigan Department of Agriculture in investigating the situation.
The recall does not involve soy oil products produced by Thumb Oilseed.
Consumers with questions may contact the company at 989-658-2344 between 9:00 am and 4:00
pm EST Monday-Friday.
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Feb. 26, 2010
OneTouch® SureStep® Test Strips Recalled
LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of
OneTouch® SureStep® Test Strips, used by people with diabetes to measure their
blood glucose levels at home. The test strips are being recalled because they may provide
falsely low glucose results when the glucose level is higher than 400 mg/dL.
The eight lots of consumer OneTouch SureStep Test Strips being recalled are:
|
| Recalled Lot |
Size |
Description |
| 2969251 |
100-ct |
OneTouch SureStep |
| 2969798 |
100-ct |
OneTouch SureStep |
| 2982369 |
100-ct |
OneTouch SureStep |
| 2983467 |
100-ct |
OneTouch SureStep |
| 2969795 |
50-ct |
OneTouch SureStep |
| 2982566 |
50-ct |
OneTouch SureStep |
| 2969481 |
50-ct |
Medicare/Mail Order |
| 2998193 |
50-ct |
Medicare/Mail Order |
|
Lot #'s are located on the outer carton and test strip vial.
Patients with test strips from the recalled lots are asked to call LifeScan at 800 5
74-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit
www.SureStep.com to request replacement product. Replacement product will be shipped
immediately and provided free of charge.
While waiting for replacement product to arrive, it is important that patients with
recalled test strips continue to test their blood glucose. Patients with access to a
meter that does not use OneTouch SureStep Test Strips should use this other meter to test
their blood glucose until replacement product from LifeScan arrives. If an alternate
meter is not available, patients may continue to test using the recalled OneTouch
SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should
contact their healthcare professional for further instructions because their glucose may
be significantly higher.
LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of
consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009
and January 28, 2010.
No injuries associated with these recalled test strips have been reported. However, if
patients use the falsely low test results to determine their insulin dose, they may give
themselves too little insulin, which could result in poor blood glucose control. Patients
with high blood glucose may or may not have certain symptoms including increased thirst,
frequent urination, headaches, difficulty with concentration, blurred vision and fatigue
(weak, tired feeling). High blood glucose must be recognized and treated promptly to
avoid serious complications, such as coma and death.
Hospitals, clinics and other multi-patient facilities using SureStep®Pro®,
SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been
notified of this issue. All three of these systems use SureStep®Pro® Test Strips
which also may provide inaccurately low test results when the blood glucose reading is
greater than 400 mg/dL. LifeScan has advised these facilities of the appropriate actions
to take in order to continue to use these SureStepPro Test Strips. However, healthcare
facilities with access to alternative means of testing should consider temporarily
discontinuing their use of their SureStep Systems until replacement test strips are
available.
This field action is limited to eight lots of OneTouch SureStep Test Strips sold for
consumer use in the U.S., and select SureStepPro Test Strips used in healthcare
facilities. Similar recall actions are being taken in other countries where the affected
product was distributed.
In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to
provide test strips. Today, OneTouch SureStep Meter users represent a very small portion
LifeScan's total customer base. The vast majority of LifeScan's customers now use
OneTouch® Ultra® Brand Meters, which use an entirely different technology.
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Feb. 25, 2010
Wholesome Spice Recalls 25 Lb. Boxes Of Crushed Red Pepper
Wholesome Spice of Brooklyn, NY is recalling all lots of 25 lb boxes of Crushed
Red Pepper sold between 4/6/09 and 1/20/10, because they have the potential to be
contaminated with Salmonella, an organism which can cause serious and sometimes fatal
infections in young children, frail or elderly people, and others with weakened immune
systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which
may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection
with Salmonella can result in the organism getting into the bloodstream and producing
more severe illnesses such as arterial infections (i.e., infected aneurysms),
endocarditis and arthritis.
The 25 lb boxes of Crushed Red pepper were distributed in the Northeastern U.S.. The
product was not sold on the retail level to consumers.
- The Crushed Red Pepper product is packaged in a clear plastic bag which is placed
inside of a cardboard box with an adhesive white label with a blue border and blue and
black lettering. The brand name on the product labels is WHOLESOME SPICES. The product
name is listed as CRUSHED RED PEPPER.
It cannot be determined at this time if this product has been related to any illnesses
to date.
The firm was informed that samples of its product have tested positive for Salmonella.
The firm is currently working with the FDA to determine how the contamination occurred.
Manufacturers who have purchased 25 lb boxes of WHOLESOME SPICES brand Crushed Red Pepper
are urged not to use the product and to recall any product they further distributed.
Manufacturers with questions may contact the firm via telephone at (718) 388-1549. Our
hours of operation are from Monday to Friday 8:30-4:30pm Eastern Standard Time.
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Feb. 25, 2010
Trader Joe's Recalls Chocolate Chip Chewy Coated Granola Bars
Trader Joe's Company of Monrovia, California is voluntarily expanding the recall of:
- Trader Joe's Chocolate Chip Chewy Coated Granola Bars (SKU 82818) - ALL code dates,
manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc.
This product has the potential to be contaminated with Salmonella, an organism which can
cause serious and sometimes fatal infections in young children, frail or elderly people,
and others with weakened immune systems. Healthy persons infected with Salmonella often
experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances,
infection with Salmonella can result in the organism getting into the bloodstream and
producing more severe illnesses such as arterial infections (i.e., infected aneurysms),
endocarditis and arthritis.
The product involved in this recall was distributed at Trader Joe's stores nationally and
comes in a 7.4 oz box. Production of the product has been suspended while FDA and
Bloomfield Bakery continue their investigation.
No illnesses have been confirmed to date in connection with this product.
Customers who have purchased Trader Joe's Chocolate Chip Chewy Coated Granola Bars are
urged to return them to any Trader Joe's for a full refund. Customers with questions may
contact Trader Joe's Customer Relations Monday through Friday, 6am to 6pm PST at (626)
599-3817.
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Feb. 23, 2010
Berry Light Cereal Healtheries Simple Recalled
Package Description & Size:
320g
Identification:
Best before date 05 02 11 107
NZ Distribution:
Supermarkets and Health food Stores throughout North Island
Reason for Recall:
Bircher Apple and Raisin Muesli which contains gluten has been wrongly packed into
Healtheries Simple Berry light Cereal boxes. Healtheries Simple Berry Light cereal is a
wheat and gluten free product
Comments:
If you are wheat or gluten intolerant or a celiac, the product must not be consumed.
There have been no reports of illness, however any person concerned about their health
should seek medical advice. Customers should return the product to their retailer for a
full refund or phone 0800 848 254 with any queries. This recall does not affect any other
Vitaco Health (NZ) Limited or Healtheries products.
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Feb. 20, 2010
Organic Peanut Crunch, Dutch Apple And Wildberry Chewy Granola Bars Recalled
Lovin Oven, LLC of Irwindale, CA announced that it has taken the precautionary measure of
voluntarily recalling certain Health Valley Organic Peanut Crunch, Dutch Apple and
Wildberry Chewy Granola Bars because they have the potential to be contaminated with
Salmonella.
The bars contain organic toasted soy grits supplied by Thumb Oilseed Producers
Cooperative of Ubly, MI which is the subject of an FDA investigation concerning recent
Salmonella outbreaks. No illnesses have been reported in connection with the recalled
bars and no other types of Health Valley brand bars are being recalled.
Salmonella is an organism which can cause serious and sometimes fatal infections in young
children, frail or elderly people, and others with weakened immune systems. Healthy
persons infected with Salmonella often experience fever, diarrhea (which may be bloody),
nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can
result in the organism getting into the bloodstream and producing more severe illnesses
such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recalled Peanut Crunch, Dutch Apple and Wildberry chewy granola bars are distributed
nationally. The only lots affected are:
|
| 6.1oz HV ORG PEANUT CRUNCH |
6.1oz HV ORG DUTCH APPLE |
6.1oz HV ORG WILDBERRY |
| 07DEC09H2 |
03JAN10H1 |
05JAN10H2 |
| 15JAN10H2 |
05FEB10H2 |
15JAN10H1 |
| 23FEB10H2 |
05FEB10H2 |
12APR10H1 |
| 28FEB10H2 |
28MAR10H2 |
06JUL10H1 |
| 28MAR10H2 |
17AUG10H1 |
08MAR10H1 |
| 29MAR10H1 |
|
|
| 13APR10H1 |
|
|
| 06SEP10H2 |
|
|
| 06NOV10H2 |
|
|
| 09FEB10H2 |
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|
Product Description and SKU (number on bottom used to scan at checkout)
- Health Valley Organic Peanut Crunch Chewy Granola Bars, 6.1 oz box, #0-35742-15483-4
- Health Valley Organic Dutch Apple Chewy Granola Bars, 6.1oz box, #0-35742-15487-7
- Health Valley Organic Wildberry Chewy Granola Bars, 6.1oz box, #0-35742-15481-0
Consumers who have purchased any products covered by this recall are urged to return them
to the store of purchase for a full refund. Consumers with questions or concerns about
the recall may call the hotline at 1-800-423-4846 (7:00 AM – 5:00 PM Mountain Time).
Consumers with questions or concerns about their health should contact their doctor.
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Feb. 20, 2010
Queseria Bendita Recalls Queso Fresco, Panela, and Requeson
Queseria Bendita ofYakima, Wash., is recalling three types of cheese:
- Queso Fresco
- Panela
- Requeson
Because they have the potential to be contaminated with Listeria monocytogenes, an
organism that can cause serious and sometimes fatal infections in young children, frail
or elderly people, and others with weakened immune systems.
Although healthy individuals may suffer only short-term symptoms such as high fever,
severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can
cause miscarriages and stillbirths among pregnant women.
The Queso Fresco, Panela, and Requeson cheeses are sold at Queseria Bendita's retail
store and were distributed in Washington and Oregon, where they are sold in Hispanic
markets.
The Queso Fresco is packaged in one and three-pound vacuum packed wheels; the Panela is
vacuum packed in one and three pound sizes; and the Requeson is packed in eight-ounce and
one pound clear plastic tubs.
Each cheese has a green label identifying the type of cheese, the Queseria Bendita brand
name, and a date code up to and including "Apr 30 2010".
To date there is one confirmed illness in Washington related to the recalled product.
Other illnesses in Washington and Oregon may also be related.
The public health investigation of the illnesses led to sampling and testing of the
cheeses. The testing revealed the contamination of the product with Listeria
monocytogenes.
The company has ceased production and distribution of the product while the Washington
State Department of Agriculture, the U.S. Food and Drug Administration, and the firm
investigate the source of the problem.
Consumers who have purchased the product are urged to return it to the place of purchase
for a full refund. Consumers with questions may contact the company at 1-509-574-8587
Monday through Friday between 9 a.m. and 5 p.m.
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Feb. 19, 2010
Unauthorized OM Fusion Distributors LLC Health Products Found on Canadian Market
Health Canada is warning consumers of unauthorized health products sold under the OM
Fusion Distributors LLC label included in the table below. The use of these products may
cause life threatening reactions. There are serious risks with taking unauthorized drugs
without supervision by a health care professional. If you take these products, you may
also prevent your physician from properly diagnosing your condition and prescribing the
correct medication.
Canadians who have purchased or used these products bearing the OM Fusion label are
advised to immediately consult a health care practitioner. Consumers are advised to
monitor the Health Canada Web site for additional updates regarding this issue.
The manufacturer packaging for the seven unauthorized products list certain ingredients
that are drugs. These ingredients should only be sold with a prescription and are
intended for use under the supervision of a health care professional only. It is illegal
to sell to the public a product containing these ingredients unless the sale is made
pursuant to a prescription.
The OM Fusion Distributors LLC label appears as a white sticker on top of the standard
manufacturer packaging and falsely represents the prescription drugs as natural health
products, such as skin care cream and dietary supplements.
|
| Unauthorized Health Product |
Reported Drug Ingredient(s) |
| Adelphane – Esidrex |
Hydrated Dihydralazine Sulphate |
| Antihemorroi Ointment |
Betamethasone Valerate |
| Erythromycin |
Erythromycin |
| Ftorocort |
Triamcinolone Acetonide |
| Levomycetin |
Chloramphenicol |
| Prednisolonum |
Prednisolonum |
| Zdorovye |
Ampicillin |
|
Consumers should exercise caution when purchasing health products. Consumers are reminded
that health products that are authorized for sale in Canada will have an eight-digit Drug
Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine
Number (DIN-HM) on the label. These numbers indicate that the products have been assessed
by Health Canada for safety, effectiveness and quality.
Health Canada reminds retailers that the sale of unauthorized drugs contravenes the Food
and Drugs Act. Sale of unauthorized drugs could render the seller liable for conviction
for an offence under the Act. As such, Health Canada advises retailers to remove these
products from their shelves and contact the Health Products and Food Branch Inspectorate
for more information.
Consumers requiring more information about this warning can contact Health Canada's
public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
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Feb. 19, 2010
Fresh & Easy Chewy Chocolate Chip Granola Bars Recalled
Fresh & Easy Neighborhood Market Inc., is voluntarily recalling all date codes of Fresh
& Easy™ Chewy Chocolate Chip Granola Bars as a result of a recall initiated by
Thumb Oilseed Producers. This company supplies an ingredient that has the potential to be
contaminated with Salmonella.
Salmonella is an organism which can cause serious and sometimes fatal infections in young
children, frail or elderly people, and others with weakened immune systems. Healthy
persons infected with Salmonella often experience fever, diarrhea (which may be bloody),
nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can
result in the organism getting into the bloodstream and producing more severe illnesses
such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
This is the only Fresh & Easy product affected and there have been no illnesses reported.
- Fresh & Easy™ Chewy Chocolate Chip Granola Bars - 6count/7.4oz carton -
CODE#: 5051379001377 - ALL Dates
The recalled products were sold in Fresh & Easy Neighborhood Market stores located in
California, Nevada, and Arizona.
Customers may return the unused product, empty product containers or present the receipt
as proof of purchase of the recalled product to any Fresh & Easy store for a full refund.
Consumers who have questions or concerns about this recall should contact the Fresh &
Easy 24-hour toll free number at 1 (800) 648-8622.
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Feb. 18, 2010
FDA Announces New Safety Controls for Medications Used to Treat Asthma
The U.S. Food and Drug Administration today announced that drugs in the class of
long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma
in children or adults. Manufacturers will be required to include this warning in the
product labels of these drugs, along with taking other steps to reduce the overall use of
these medications.
These new requirements are based on FDA analyses of clinical trials showing that use of
these long-acting medicines is associated with an increased risk of severe worsening of
asthma symptoms, leading to hospitalization in both children and adults and death in some
patients with asthma. The drugs involved include:
- single agent products Serevent and Foradil
- combination medications Advair and Symbicort that also contain inhaled
corticosteroids.
These medications improve a patient's ability to breathe freely and reduce the symptoms
of asthma by relaxing muscles in the lung's airways.
The FDA will now require that the product labels reflect the following:
-
The use of LABAs is contraindicated without the use of an asthma controller medication
such as inhaled corticosteroid. Single-agent LABAs should only be used in combination
with an asthma controller medication; they should not be used alone;
-
LABAs should only be used long-term in patients whose asthma cannot be adequately
controlled on asthma controller medications;
-
LABAs should be used for the shortest duration of time required to achieve control of
asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients
should then be maintained on an asthma controller medication.
-
Pediatric and adolescent patients who require a LABA in addition to an inhaled
corticosteroid should use a combination product containing both an inhaled corticosteroid
and a LABA to ensure compliance with both medications.
"Although these medicines play an important role in helping some patients control asthma
symptoms, our review of the available clinical trials determined that their use should be
limited, whenever possible, due to an increased risk of asthma exacerbations,
hospitalizations and death," said Badrul Chowdhury, M.D., director of the Division of
Pulmonary and Allergy Products in the FDA's Center for Drug Evaluation and Research.
"The risks of hospitalization and poor outcomes are of particular concern for children;
parents need to know that their child with asthma should not be on a LABA alone," said
Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics.
LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary
disease (COPD). The new recommendations only apply to the use of LABAs in the treatment
of asthma.
The FDA will be requiring the manufacturers of LABAs to conduct additional studies to
further evaluate the safety of LABAs when used in combination with inhaled
corticosteroids. The FDA will seek input on the design of these studies at a public
advisory committee meeting in March 2010.
In addition to these actions, FDA will work with public and private partners under the
agency's ongoing Safe Use Initiative to study LABA prescribing practices.
"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns
adjust to the new recommendations for this class of asthma drugs. If prescribing patterns
don't adjust, we will determine the reasons and consider additional steps to support safe
prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation
and Research.
The Safe Use Initiative, launched in November, strives to reduce preventable harm by
identifying specific, preventable medication risks and developing, implementing and
evaluating cross-sector interventions with public and private partners who are committed
to safe medication use.
- Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline
- Foradil is marketed by Lebanon, PA-based Novartis AG
- Symbicort is marketed by Wilmington, DE-based AstraZeneca
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Feb. 17, 2010
FDA Warns about Serious Side Effects from Maalox Product Mix-Ups
The U.S. Food and Drug Administration today warned consumers about the potential for
serious side effects from mistakenly using Maalox Total Relief instead of other
Maalox products. The two products are intended for the relief of different
symptoms and contain different active ingredients.
Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication,
while traditional Maalox liquid products Maalox Advanced Regular Strength
and Maalox Advanced Maximum Strength are antacids. Both Maalox Total Relief
and Maalox are made by Novartis Consumer Health Inc. (NCH) and are available
without a prescription as over-the-counter liquid medications. The maker of Maalox
brand products has agreed to change the name of Maalox Total Relief to one that
does not include the word "Maalox" and will change the drug's packaging to avoid further
confusion.
"Maalox Total Relief and Maalox are not interchangeable and shouldn't be
used in place of each other," says Carol Holquist, R.Ph., director of FDA's Division of
Medication Error Prevention and Analysis. "Consumer confusion and incorrect product use
due to name confusion are serious public health issues. We appreciate Novartis' efforts
to work collaboratively with FDA and their decision to remedy this situation to avoid any
confusion over Maalox products in the future."
Maalox Total Relief's active ingredient (bismuth subsalicylate) is chemically
related to aspirin and may cause similar harmful side effects such as bleeding. As such,
Maalox Total Relief is not appropriate for individuals with a history of
gastrointestinal ulcer disease or a bleeding disorder.
Maalox Total Relief also
should not be taken by children and teens if they are recovering from a viral infection,
nor by individuals who are taking certain medications including: oral antidiabetic drugs
(OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and
clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other
anti-inflammatory drugs.
Packaging and labeling of Maalox Total Relief and traditional Maalox Advanced
Regular Strength and Maalox Advanced Maximum Strength are very similar and
easily confused. Due to this confusion, NCH has agreed to:
-
Change the name of Maalox Total Relief to one that does not include the root name
Maalox as well as change the product label design;
-
Conduct an educational campaign with outreach to healthcare professionals and consumers
regarding different Maalox products and ways to select the appropriate
Maalox brand product; and
-
Actively monitor and report adverse events associated with the use of Maalox brand
products.
"The FDA is concerned about the public health impact of medication mix-ups for products
that have the same names or portions of the same name, but contain different active
ingredients," said Ms. Holquist. "We want companies to consider the potential for name
confusion when choosing names for their drugs."
The renamed product is expected to begin selling in September 2010. Until that time, FDA
is advising consumers and healthcare professionals to carefully check the labels of all
Maalox products to ensure the appropriate product is being selected for the
patient's symptoms.
Any Maalox side effects or other product problems should be reported to FDA's
MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling
1-800-332-1088.
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Feb. 17, 2010
Estrella Family Creamery Expands Recall Of Various Cheeses
Estrella Family Creamery of Montesano, WA is recalling:
- Brewleggio
- Domino
- Wynoochee River Blue cheeses
Because they have the potential to be contaminated with Listeria monocytogenes, an
organism which can cause serious and sometimes fatal infections in young children, frail
or elderly people, and others with weakened immune systems. Although healthy individuals
may suffer only short-term symptoms such as high fever, severe headache, stiffness,
nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and
stillbirths among pregnant women.
The products were sold to restaurants and cheese shops in WA, OR, and NJ.
-
The Domino cheese is a one pound, natural rind wheel made from cow's milk
-
The Brewleggio cheese is a soft washed rind cow's milk wheel 8" wide by 2" tall, weighing
approximately 3 pounds
-
The Wynoochee River Blue Cheese is a 5 pound wheel with a rustic natural rind, blue
veined.
The products are not coded. No illnesses have been reported to date.
The recall, which initially included Red Darla cheese, has now been expanded to include
Domino Cheese that also tested positive for Listeria monocytogenes. Brewleggio and
Wynoochee River Blue cheeses are also being included in the expanded recall because they
were aged in the same room as the Domino cheese. The company has ceased the production
and distribution of the products as the Washington State Department of Agriculture, the
Food and Drug Administration, and the company continue their investigation as to what
caused the problem.
Consumers can return any remaining product to the place of purchase for a full refund.
Any questions can be answered by Kelli or Anthony at the Creamery, 360.249.6541, Monday –
Friday, 6:00am – 8:00pm PST.
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Feb. 17, 2010
Retail List for Recalled Beef Products
FSIS has reason to believe that the following retail location(s) received beef and veal
products that have been recalled by Huntington Meat Packing Inc. This list may not
include all retail locations that have received the recalled product or may include
retail locations that did not actually receive the recalled product. Therefore, it is
important that you use the product-specific identification information in addition to
this list of retail stores, to check meat or poultry products in your possession to see
if they have been recalled.
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Feb. 17, 2010
Daniele International Expands Recall of Italian Sausage Products
Daniele International Inc., an establishment with operations in Pascoag and Mapleville,
R.I., is expanding its January 23 recall to include approximately 115,000 pounds of
salami/salame products that may be contaminated with Salmonella, the U.S. Department of
Agriculture's Food Safety and Inspection Service (FSIS) announced today.
The recall is being expanded as a result of a confirmed finding of Salmonella in an
unopened salami product tested by FSIS, and by ingredient testing performed by the
company. The product was sampled during the course of an ongoing investigation of a
multi-state outbreak of Salmonella serotype Montevideo illnesses. These products were not
subject to recall previously because they are not sausage products that contain black
pepper on the external surface, or packaged with such products. Based on preliminary
testing results, the company believes that crushed red pepper may be a possible source of
Salmonella contamination.
Further testing is ongoing at a state health partner laboratory, and may determine if the
product contained the Salmonella Montevideo strain associated with the multi-state
outbreak. The Centers for Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA), FSIS, state health and agriculture departments, and Daniele
International are cooperating in this investigation. The CDC has posted information about
the multi-state outbreak on its
website but the investigation is ongoing and the root cause of the contamination has
not yet been determined.
FSIS is continuing to work with the CDC, FDA, affected state public health partners, and
the company on the investigation and will update the public on the progress of this
investigation as information becomes available.
The products subject to recall include:
- 8-ounce packages of "DANIELE HOT SALAME PANINO WITH FRESH MOZZARELLA."
- 8-ounce packages of "BOAR'S HEAD SALAME PANINO, SALAME ROLLED IN MOZZARELLA CHEESE."
- 8-ounce packages of "DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN
MOZZARELLA CHEESE."
- Random weight packages of "DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN
MOZZARELLA CHEESE."
- 8-ounce packages of "DIETZ & WATSON ARTISAN COLLECTION HOT SALAME PANINO, HOT SALAME
ROLLED IN MOZZARELLA CHEESE."
- 8-ounce packages of "DANIELE SALAME PANINO WITH FRESH MOZZARELLA AND BASIL."
- 1-pound 8-ounce variety packages of "DANIELE CAPOCOLLO PANINO WITH FRESH MOZZARELLA
AND BASIL; PRESIDENT'S PROSCIUTTO PANINO WITH FRESH MOZZARELLA AND BASIL; HOT SALAME
PANINO WITH FRESH MOZZARELLA," with UPC Code 736436709582. NOTE: The products contained
in this variety three-pack may be sold individually as well.
Each package bears a label with establishment number "EST. 459" inside the USDA mark of
inspection. The above products are sold individually packed, except as noted above. The
products subject to recall have sell-by dates ranging from February 3, 2010, through May
26, 2010, and were distributed to retail establishments nationwide. When available, the
retail distribution list(s) will be posted on
FSIS' website.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify
their customers (including restaurants) of the recall and that steps are taken to make
certain that the product is no longer available to consumers.
Consumers with questions about the recall should contact the company's Hotline at (888) 3
45-4160. Media with questions about the recall should contact the company's public
relations contact, Levick at (202) 973-1335.
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Feb. 15, 2010
Drug Alert: Citanest 1% Solution
AstraZeneca UK Ltd
Citanest 1% solution for injection multi-dose vials 10mg/ml
Prilocaine Hydrochloride
PL 17901/0118
AstraZeneca UK Ltd is recalling all remaining stock of batches of the above product expiring
before the end of 2011. This action is being taken because routine stability testing has
indicated that the preservative levels may become too low after 24 months from manufacture.
A list of the batches to be recalled is included below.
For medical information enquiries please contact AstraZeneca UK medical information on 0800
783 0033. Any affected batches should be returned via its agents - AAH Pharmaceuticals or
Alliance Healthcare where credit will be issued. For any further stock enquiries please
contact AstraZeneca UK Supply Chain Team on 0800 032 0501.
List of 12 batches of Citanest 1% Solution for injection Multi-dose vials 10mg/ml to be
recalled:
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| Batch Number |
Expiry date |
Pack size |
First distributed |
| FX337 |
2/12/2011 |
1X50ML |
March 2009 |
| FS216 |
30/6/2011 |
1X50ML |
January 2009 |
| FP186 |
29/5/2011 |
1X50ML |
December 2008 |
| FM069 |
19/5/2011 |
1X50ML |
October 2008 |
| FJ545 |
26/3/2011 |
1X50ML |
August 2008 |
| FF738 |
14/12/2010 |
1X50ML |
May 2008 |
| FD238 |
11/12/2010 |
1X50ML |
March 2008 |
| FA944 |
5/9/2010 |
1X50ML |
January 2008 |
| EY517 |
28/8/2010 |
1X50ML |
November 2007 |
| EX030 |
25/7/2010 |
1X50ML |
October 2007 |
| EV669 |
2/5/2010 |
1X50ML |
October 2007 |
| EV050 |
2/5/2010 |
1X50ML |
August 2007 |
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Feb. 13, 2010
Hellers Sensational Chinese Honey Sausages Recalled
Name of Product:
Hellers Sensational Chinese Honey Sausages
Package Description & Size:
1kg
Identification:
Use by date 180310
NZ Distribution:
On sale in Supermarkets throughout North Island since 05 February 2010
Reason for Recall:
Incorrect labelling and product contains dairy allergens. The product is actually Chunky
cheese sausages which have been incorrectly packaged as Chinese honey
Comments:
There have been no reports of illness, however any person concerned about their health
should seek medical advice. Customers should return the product to their retailer for a
full refund or phone 0800 HELLERS with any queries. This recall does not affect any other
Hellers products.
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Feb. 13, 2010
Huntington Meat Packing Expands Recall on Beef Products
Huntington Meat Packing Inc., a Montebello, Calif., establishment, is expanding its recall
of January 18 to include
approximately 4.9 million additional pounds of beef and veal products that were not produced
in accordance with the company's food safety plan. The products are adulterated because the
company made the products under insanitary conditions failing to take the steps it had
determined were necessary to produce safe products, the U.S. Department of Agriculture's
Food Safety and Inspection Service (FSIS) announced today. FSIS has received no reports of
illnesses associated with consumption of these products. Individuals concerned about an
illness should contact a physician.
The recall was expanded based on evidence collected in an ongoing criminal investigation
being conducted by the Office of the Inspector General (OIG) with assistance from FSIS. This
evidence shows that the products subject to this recall expansion were produced in a manner
that did not follow the establishment's Hazard Analysis and Critical Control Points (HACCP)
plan. A HACCP plan describes the process controls an establishment must take to prevent food
safety hazards and create a safe and wholesome product. The investigation has uncovered
evidence to show that the food safety records of the establishment cannot be relied upon to
document compliance with the requirements. Therefore, FSIS must consider the products to be
adulterated and has acted to remove the products from commerce.
The following beef and veal products, produced by the plant from January 22, 2009, to
January 4, 2010, are subject to recall:
- 10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
- 10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"
- 20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
- 50 lb. boxes of "HUNTINGTON MEATS GROUND BEEF"
- 50 lb. boxes of " HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
- 50 lb. boxes of "BEEF BURRITO FILLING MIX"
- 50 lb. boxes of "HUNTINGTON MEAT PKG. INC. DICED BEEF"
- 50 lb. boxes of "HUNTINGTON MEAT PKG. INC. SLICED BEEF"
- 10 lb. boxes of "Huntington Meat VEAL PATTY"
- 10 lb. boxes of "Imperial Meat VEAL PATTY"
- 10 lb. boxes of "El Rancho VEAL PATTY"
- 20 lb. boxes of "Huntington Meat VEAL PATTY"
- 20 lb. boxes of "Imperial Meat VEAL PATTY"
- 20 lb. boxes of "El Rancho VEAL PATTY"
Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a
label. The products were produced between January 22, 2009, and January 4, 2010, and were
shipped to distribution centers, restaurants, and hotels within the State of California.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their
customers (including restaurants) of the recall and that steps are taken to make certain
that the product is no longer available to consumers.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and
frozen, and only consume ground beef or ground beef patties that have been cooked to a
temperature of 160° F. The only way to be sure ground beef is cooked to a high enough
temperature to kill harmful bacteria is to use a food thermometer to measure the internal
temperature.
Media and consumer questions regarding the recall should be directed to the company Owner
Robert Glenn at (323) 726-9714.
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Feb. 12, 2010
Recall On Nature's Variety Raw Frozen Chicken Diets
Nature's Variety has initiated a voluntary recall of their Chicken Formula Raw Frozen Diet
for dogs and cats with a "Best If Used By" date of 11/10/10 because these products may be
contaminated with Salmonella. The only products affected are limited to chicken medallions,
patties, and chubs with a "Best If Used By" date of 11/10/10. No other Nature's Variety
products are affected.
The affected products are limited to the Nature's Variety Chicken Formula Raw Frozen Diet
packaged in the following forms:
- 3 lb chicken medallions (UPC# 7 69949 60130 2) with a "Best If Used By" date of 11/10/10
- 6 lb chicken patties (UPC# 7 69949 60120 3) with a "Best If Used By" date of 11/10/10
- 2 lb chicken chubs (UPC# 7 69949 60121 0) with a "Best If Used By" date of 11/10/10
The "Best If Used By" date is located on the back of the package above the safe handling
instructions. The affected product was distributed through retail stores and internet sales
in the United States, and in limited distribution in Canada.
If you are a consumer and have purchased one of the affected products, please return the
unopened product to your retailer for a full refund or replacement. If your package has
been opened, please dispose of the raw food in a safe manner by securing it in a covered
trash receptacle. Then, bring your receipt (or the empty package in a sealed bag) to your
local retailer for a full refund or replacement.
Nature's Variety became aware of a potential problem after receiving a consumer complaint.
Subsequent testing indicated that the lot code related to the consumer complaint tested
negative for Salmonella. However, additional subsequent testing found the "Best If Used By"
date of 11/10/10 to be contaminated with Salmonella.
No pet or human illnesses have been reported to date in connection with this lot code.
Reed Howlett, Nature's Variety CEO, stated, "Because pet health and safety are our top
priority, Nature's Variety takes every step necessary to ensure the quality and safety of
our products. In addition to our industry best manufacturing practices, and in an abundance
of caution, all Nature's Variety raw frozen products now will undergo a ‘test and hold'
period before being released for sale."
Salmonella can affect both humans and animals. Even though no illnesses have been reported,
consumers should follow the Safe Handling Guidelines published on the Nature's Variety
package when disposing of the affected product. People handling raw frozen pet foods may
become infected with Salmonella, especially if they have not followed the safe handling
guidelines set forth by the company.
Healthy people infected with Salmonella may experience some or all of the following
symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, or fever.
Although rare, Salmonella can result in more serious ailments including arterial infections,
endocarditis (inflammation of the lining of the heart), arthritis, muscle pain, eye
irritation, or urinary tract symptoms. Consumers exhibiting these signs after having contact
with the affected product should contact their health care provider.
Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea,
fever, or vomiting. Some pets may experience only a decreased appetite, fever, or abdominal
pain. Infected, but otherwise healthy pets can be carriers and infect other animals or
humans. If your pet has consumed any of the affected products and is experiencing any of
these symptoms, please contact your veterinarian.
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Feb. 12, 2010
Red Darla Cheese Recalled
The Estrella Family Creamery of Montesano, Washington, is recalling its Red Darla cheese
because it has the potential to be contaminated with Listeria monocytogenes, an organism
which can cause serious and sometimes fatal infections in young children, frail or elderly
people, and others with weakened immune systems. Although healthy individuals may suffer
only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal
pain and diarrhea, Listeria infections can cause miscarriages and stillbirths among pregnant
women.
Red Darla cheese was sold in January 2010 through February 11, 2010 at:
- the Ballard and Seattle's U-District farmer's markets
- two Seattle restaurants
- retail stores in the Seattle-Tacoma area
- the firm's retail store in Montesano, Washington
- a retail market in San Francisco, California
- a cheese shop in Springfield, New Jersey
The recalled cheese is a soft cheese, 3/4 lb wheel, made of cow milk and washed in red wine
while aging. The product does not contain a lot code.
No illnesses in connection with this product have been reported to date.
The recall is the result of a routine sampling program by the state of Washington Department
of Agriculture, which revealed that one wheel of the finished product contained the Listeria
monocytogenes bacteria. Estrella Family Creamery has ceased production and distribution of
the product as the FDA, WSDA, and the company continue investigating the cause of the
problem.
Consumers who have any Red Darla should return the cheese to the place of purchase for a
full refund. Consumers with questions may contact the company at 360.249.6541 between 6:00am
– 8:00pm PST.
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Feb. 12, 2010
Trader Joe's Chocolate Chip Chewy Coated Granola Bars
Trader Joe's Company of Monrovia, California is voluntarily recalling:
- Trader Joe's Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes
16JUL10H2 and 17JUL10H1
Manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the
potential to be contaminated with Salmonella, an organism which can cause serious and
sometimes fatal infections in young children, frail or elderly people, and others with
weakened immune systems. Healthy persons infected with Salmonella often experience fever,
diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with
Salmonella can result in the organism getting into the bloodstream and producing more severe
illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The product involved in this recall was distributed at Trader Joe's stores nationally and
comes in a 7.4 oz box marked with Use by/Lot Codes 16JUL10H2 and 17JUL10H1 on the top of the
box and stamped individually on the side of each granola bar. Production of the product has
been suspended while FDA and Bloomfield Bakery continue their investigation.
No illnesses have been reported to date in connection with this product.
At Trader Joe's we take the safety of our customers and the integrity of our products very
seriously. Customers who have purchased Trader Joe's Chocolate Chip Chewy Coated Granola
Bars, Use by/Lot Codes 16JUL10H2 and 17JUL10H1 are urged to return them to any Trader Joe's
for a full refund. Customers with questions may contact Trader Joe's Customer Relations
Monday through Friday, 6am to 6pm PST at (626) 599-3817.
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Feb. 12, 2010
Giant and Stop & Shop Recalls 24 oz. Party Platter Cookies
Giant Food of Landover, Md. and The Stop & Shop Supermarket Company have announced a
voluntary recall of its 24 oz. Party Platter
Cookies because they contain almonds and almond paste, undeclared allergens that pose a
serious and potential life-threatening health risk to allergic individuals. Giant has
removed from sale the following product:
- Giant Food Party Platter Cookies
UPC# 0200148262, 24 oz., all codes
- Stop & Shop Party Platter Cookies
UPC# 200055639, 24 oz. all codes
The product is packaged on a rectangular platter with a plastic overwrap and sold through
Giant's In-Store Bakery and Stop & Shop In-Store Bakery.
To date, Giant has received no reports of illnesses associated with the consumption of this
product. Customers who have purchased the product should discard any unused portions and
bring their purchase receipt to any Giant supermarket for a full refund. Customers looking
for additional information are encouraged to call Giant's corporate brands consumer line at
(877) 846-9949 Monday through Friday from 9 a.m. to 4 p.m. Stop & Shop Customers who have
purchased the product should discard any unused portions and bring their purchase receipt to
any Stop & Shop supermarket for a full refund. Customers looking for additional information
are encouraged to call Stop & Shop's corporate brands consumer line at 1-877-846-9949,
Monday through Friday from 9am – 4pm.
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Feb. 11, 2010
Heinz Fruity Custard Fruit Medley Recalled
The public will wish to be aware that Heinz is recalling a certain batch and date code of
Heinz Fruity Custard Fruit Medley baby food due to potential presence of small plastic
pieces.
The implicated product mentioned below is being recalled. Point of sale notices will
be displayed in those stores that stocked the affected product. These notices alert
customers to the recall and advise them of what actions to take if they have purchased the
product.
The product recalled is:
-
Heinz Fruity Custard Fruit Medley
Plastic pouches 4x100g
Batch code: 9307
Best before: 03/11/10
No other Heinz products are known to be affected.
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Feb. 10, 2010
Ready-To-Eat Sausage Products Recalled
Schmalz European Provisions, a Springfield, N.J., establishment, is recalling approximately
1,485 pounds of ready-to-eat sausage products that may contain foreign materials, the U.S.
Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.
The product subject to recall includes:
-
12-ounce packages of "Applegate Farms CERTIFIED ORGANIC FIRE ROASTED RED PEPPER FULLY
COOKED CHICKEN & TURKEY SAUSAGE." Each package also indicates "KEEP REFRIGERATED" and
"SKINLESS" on the label.
Each package has a USE BY/FREEZE BY date of February 28, 2010 and "Heating Instructions" on
the back of the label. Also, the products bear the establishment number "P-5411" inside the
USDA mark of inspection. The products were produced on January 7, 2010 and were distributed
to retailers in:
|
- California
- Connecticut
- Florida
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- Georgia
- Indiana
- New Hampshire
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- New Jersey
- New York
- North Carolina
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The problem was discovered after the company reported consumer complaints about finding
plastic materials in the product. FSIS has not received any consumer complaints or reports
of injury at this time. Anyone concerned about an injury from consumption of this product
should contact a physician.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their
customers of the recall and that steps are taken to make certain that the product is no
longer available to consumers.
Consumers with questions about the recall should contact Emily Colon, Quality Assurance
Specialist, at (800) 587-5858. Media with questions about the recall should contact Gina
Asoudegan, Public Affairs, at (800) 587-5858.
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Feb. 10, 2010
Frozen Cured Pork Patty Mix Recalled
Champ Meatball Co., a Whittier, Calif., establishment, is recalling approximately 750 pounds
of frozen cured pork patty mix because it contains an undeclared allergen, wheat, the U.S.
Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. Wheat
is a known potential allergen, which is not declared on the label.
The product subject to recall includes:
-
14-ounce packages of frozen "CHAMP, Nem Nuong Cured Pork Patty Mix for Barbecue Meat
Balls." Each package bears the establishment number "EST. 21436" inside the USDA mark of
inspection.
The frozen cured pork patty mix products were produced on various dates, and were
distributed to retail establishments and restaurants in Arizona and California.
The problem was discovered by FSIS. FSIS and the company have received no reports of adverse
reactions due to consumption of these products. Anyone concerned about an allergic reaction
should contact a physician.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their
customers (including restaurants) of the recall and that steps are taken to make certain
that the product is no longer available to consumers.
Consumer and media with questions about the recall should contact company Owner Krid
Hansaward at (562) 693-7836.
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Feb. 10, 2010
'Complete 7-Day Cleanse' Recalled
Health Canada is advising consumers that the unauthorized product 'Complete 7-Day Cleanse'
is being recalled because it contains a number of active ingredients with a combined effect
that may pose serious health risks. 'Complete 7-Day Cleanse' is a multi-ingredient natural
health product promoted for 'cleansing' or removing toxins from the body.
According to package labelling, the product contains over 30 active ingredients, some having
a diuretic (water pill) or laxative (stimulant, and bulk-forming) effect. This combination
of ingredients may increase the laxative or diuretic impact of the product and pose a risk
of dehydration and/or electrolyte imbalance.
Symptoms of severe dehydration may involve an altered mental state and dizziness. Symptoms
of moderate to severe electrolyte imbalance (which is an imbalance of salts in the body,
such as potassium or sodium) may include muscle weakness or cramping, abnormal heartbeat,
and difficulties breathing.
The product is available at retail outlets across Canada and over the Internet. The Canadian
importer, Iovate Health Sciences International Inc., of Oakville, Ontario, has initiated a
nationwide recall at the request of Health Canada.
Canadians who have used 'Complete 7-Day Cleanse' and are concerned about their health should
speak to a health care practitioner. Individuals should be aware of signs or symptoms of
dehydration or electrolyte imbalance, as described above.
Drugs and natural health products that are authorized for sale in Canada will have either an
eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a
Homeopathic Medicine Number (DIN-HM) on the label. This authorization indicates that the
products have been assessed by Health Canada for safety, effectiveness and quality.
Consumers requiring more information about this advisory can contact Health Canada's public
enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
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Feb. 9, 2010
Recall of IV Extension Sets with BD Q-Syte Luer Access Device
Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of
certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD
Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson
and Company). Use of the affected BD Q-Syte™ Luer Access Device may cause an air
embolism or leakage of blood and/or therapy, which may result in serious injury or death.
This field corrective action included notification to customers worldwide by letter.
The IV Extension Set with BD Q-Syte™ Luer Access device is intended for use with other
infusion therapy products in the administration of fluids into the intravenous system.
The following REF (catalog) and lot numbers, which were sold in the U.S., are included in
the recall:
MPS Acacia IV Extension Set with BD Q-Syte
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REF or Catalog Numbers:
- 385150
- 385151
- 385164
- 385165
- 385166
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Lot Numbers:
- A1950
- A1951
- A1967
- A1979
- A2055
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Lot Numbers:
- A2056
- A2099
- A2100
- A2101
- A2104
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Patient safety and the quality and safety of our products are Acacia's first priorities.
The recall was initiated on Dec. 18, 2009 after Acacia received information from BD of
complaints received due to air entry through the bottom disk of the Q-Syte™ septum.
BD investigated and determined the root cause to be a manufacturing deviation. Though Acacia
has not received any customer notification of product failures with the Acacia IV Extension
Sets with BD Q-Syte™, product failures occurred with BD labeled devices that included
BD Q-Syte™ units distributed from November 2008 through November 2009.
The root cause has been corrected by BD and preventive measures, including additional
inspections and preventive maintenance of the line, have been implemented.
The approximately 217,000 IV Extension Sets with BD Q-Syte™ that were recalled were
distributed in the United States exclusively to BD for distribution worldwide, which
includes the United States, Canada, Europe, Asia, Australia, and North and South American
Countries.
Acacia has notified the U.S. Food and Drug Administration and other worldwide health
agencies, as necessary, and is working with them to coordinate recall activities.
Clinicians or distributors with questions can contact Acacia at 1-800-486-6677 between 8:00
AM and 5:00 PM Pacific Standard Time, Monday-Friday, or dial directly at 714-257-0470.
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Feb. 9, 2010
Turkey Hill Dairy Issues Recall On Chocolate Marshmallow Ice Cream
Turkey Hill Dairy of Conestoga, Pa., is recalling its:
- 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream
Because the product may contain almonds that were inadvertently added during production.
No illnesses have been reported to date in connection with this issue, although people who
have allergies to almonds run the risk of serious or life-threatening allergic reactions if
they consume these products. The product is safe for consumption by consumers without nut
allergies.
The recalled Chocolate Marshmallow Premium Ice Cream is limited only to select stores in
central Pennsylvania. All affected stores are directly delivered to and serviced by Turkey
Hill Dairy and have been instructed to remove the product from their shelves.
The recall was initiated after it was discovered that the recalled product was distributed in
packaging that did not identify almonds as an ingredient. It is believed that less than 150
containers of ice cream were potentially exposed to almonds. All affected containers would
have been purchased by consumers after January 28, 2010
The product comes in a rounded, rectangular, cream-colored, paperboard, 48 oz. packages with
farm scene and ice cream scoop graphics. The affected product is marked on the bottom of the
package with the code "01/18/2011 56/L1". Preceding the code is a four-digit number
indicating the production time. The recalled product includes a time between 02:25 and 02:35.
Consumers who have purchased affected 48 oz. packages of Chocolate Marshmallow Premium Ice
Cream with the previously mentioned code can return them to the place of purchase for a full
refund. Consumers with questions may contact Turkey Hill Dairy at 1-800-MY-DAIRY
(1-800-693-2479).
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Feb. 4, 2010
Pork Barbecue Products Recalled Due to Undeclared Allergen
The Murphy House, a Louisburg, N.C., establishment, is recalling approximately 2,850 lbs.
of pork barbecue products because they may contain an undeclared allergen, soy flour, the
U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced
today. Soy flour is a known potential allergen, which is not declared on the label.
The product subject to recall includes:
-
5-lbs. buckets of "The MURPHY HOUSE PREMIUM PORK BARBECUE; COOKED, UNSKINNED, PORK WITH
BARBECUE SAUCE ADDED" Each package bears the establishment number "EST. 2135" inside the
USDA mark of inspection.
The pork barbecue products were sent to distributors and restaurants in the North Carolina
region.
The problem was discovered during a routine review of operations by FSIS at the
establishment. FSIS has received no reports of adverse reactions due to consumption of
these products. Anyone concerned about an allergic reaction should contact a physician.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their
customers of the recall and that steps are taken to make certain that the product is no
longer available to consumers.
Consumer and media inquiries regarding the recall should be directed to Josh Whitely, Vice
President, at (919) 496-6054.
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Feb. 4, 2010
Recalled Italian Sausage Products (Update)
As part of the continuing investigation, this recall release is being updated on February
4, 2010, to include two additional products, adding approximately 23,754 pounds to the
January 23 recall. It should be noted that these additional products are separate from
those listed on the
January 31 expansion.
The two additional products are:
- 3-ounce packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."
- Approximately 6-pound packages of "DANIELE SALAME GRANDE COATED WITH PORK FAT &
PEPPER."
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Feb. 4, 2010
Alert On Uneviscerated Whole Schmaltz Herring
Haifa Smoked Fish, located in Queens, New York, is recalling Haifa brand vacuum packaged
Whole Schmaltz Herring with the lot number 20, because the product was found to be
uneviscerated.
The lot being recalled is a product of Norway, individually vacuum-packed in clear plastic
pouches with lot # 20 indicated on the label and distributed through various food
retailers in the NY and NJ area.
The Whole Schmaltz Herring was sampled by a New York State Agriculture and Markets Food
Inspector during a routine inspection. Subsequent analysis of the product by New York
State Food Laboratory personnel confirmed that Whole Schmaltz Herring was not properly
eviscerated prior to processing.
The sale of uneviscerated fish is prohibited under New York State Agriculture and Markets
regulations because of Clostridium Botulinum spores are more likely to be concentrated in
the viscera than any other portion of the fish. Uneviscerated fish has been linked to
outbreaks of botulism poisoning.
Botulism is a serious and potentially fatal form of food poisoning, causes the following
symptoms: general weakness, dizziness, double-vision and trouble with speaking or
swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and
constipation may also be common symptoms. People experiencing these problems should seek
immediate medical attention.
No illnesses have been reported to date in connection with this problem.
Consumers are warned not to use the product even if it does not look or smell spoiled and
should return it to the place of purchase. Consumers with questions may contact the
company at 718-523-8899.
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Feb. 4, 2010
Dangers Related to Furniture, Television and Appliance Tip-Overs
Health Canada is advising parents and caregivers to take precautionary steps to help
minimize the dangers related to television, furniture and appliance tip-overs. According
to data from the Canadian Hospitals Injury Reporting and Prevention Program, there have
been more than 5,000 reports of televisions, furniture and appliances falling over onto
children under 10 years of age since 1990. Furniture or television tip-overs can cause
serious head and internal injuries, as well as suffocation, which can lead to death. More
than 70% of the reported television tip-over incidents in Canada happened to children
between one and three years of age.
Common circumstances that can lead to tip-over incidents include children:
- climbing on furniture, televisions or appliances
- reaching for items such as toys or remote controls located on elevated surfaces
- pushing, pulling or accidentally bumping into televisions or pieces of furniture
Take these simple steps to help minimize the danger in your home:
-
Always supervise children in the home and teach them not to climb on or hang from
furniture.
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Choose storage furniture, such as bookcases, cabinets, television stands, and dressers,
with a wide and stable base that sits directly on the floor. Models with legs or wheels
are more likely to tip-over.
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Attach furniture to the floor or wall stud using the appropriate angle braces, anchors or
safety straps. If these items come with the product, follow the manufacturer's
instructions for installation.
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Place televisions far back on low stable furniture that is designed to hold the weight and
size of the television. Attach the television to the stand, if possible.
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Keep electric cords behind furniture where children cannot reach them.
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Do not place items that may appeal to a child, such as toys, plants and remote controls,
on top of a television or tall furniture.
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Do not place heavy items on top of elevated surfaces.
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Regularly check that furniture, televisions and appliances are stable and secure and that
electrical cords are out of children's reach.
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For furniture with drawers, only open one drawer at a time to reduce the chance that it
will tip over; completely close all drawers when not in use so they cannot be used as
steps by a child; place heavier items in lower drawers; and install locking devices on
each drawer if you have young children.
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Do not assemble and use the furniture if instructions are not provided or if you cannot
follow the instructions.
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Verify a product's label, visit the manufacturer's website or ask the retailer to find out
what safety features are available for the furniture you are considering.
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Always use furniture for its intended purpose.
To report a tip-over related consumer complaint or incident, please contact your regional
Health Canada Product Safety office toll free at 1-866-662-0666 or by e-mail at
cps-spc@hc.gc.ca (please indicate the province or
territory from which you are corresponding).
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Feb. 2, 2010
Recall: Fresh Boneless Beef Products
West Missouri Beef, LLC, a Rockville, Mo., establishment, is recalling approximately
14,000 pounds of fresh boneless beef products that may be contaminated with E. coli
O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS)
announced today.
The following products are subject to recall:
- One combo bin containing approximately 2,000 pounds of fresh boneless beef identified
as "75 1-M," produced on October 26, 2009.
- One combo bin containing approximately 2,000 pounds of fresh boneless beef identified
as "90 3-D," produced on November 25, 2009.
- One combo bin containing approximately 2,000 pounds of fresh boneless beef identified
as "90 5-D," produced on November 27, 2009.
- Combo bins containing approximately 2,000 pounds of fresh boneless beef identified as
"90 2-P," "90 2-R" or "90 2-V," produced on December 8, 2009.
- One combo bin containing approximately 2,000 pounds of fresh boneless beef identified
as "90 3-E," produced on January 13, 2010.
Each container is marked with the establishment number "EST. 5821" inside the USDA mark of
inspection. The fresh boneless beef products were distributed to wholesalers in the
Chicago, Ill., area.
The problem was discovered by FSIS during a verification review performed at the
establishment.
FSIS has received no reports of illnesses associated with consumption of these products.
Individuals concerned about an illness should contact a physician.
E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea,
dehydration, and in the most severe cases, kidney failure. The very young, seniors and
persons with weak immune systems are the most susceptible to foodborne illness.
Individuals concerned about an illness should contact a physician.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their
customers of the recall and that steps are taken to make certain that the product is no
longer available to consumers.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and
frozen, and only consume ground beef or ground beef patties that have been cooked to a
temperature of 160° F. The only way to be sure ground beef is cooked to a high enough
temperature to kill harmful bacteria is to use a food thermometer to measure the internal
temperature.
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Feb. 2, 2010
Allergy Alert: Aahu Barah Brand Dry Apricot
Global Commodities Inc. of Hicksville, NY is recalling its 0.50 lbs. packages of Aahu
Barah brand Dry Apricot food treats because they contain undeclared Sulfites. People who
have allergies to Sulfites run the risk of serious or life-threatening allergic reaction
if they consume this product.
The recalled Dry Apricots were distributed in New York State in some retail stores. The
product comes in a 0.50 lbs., clear plastic package marked with Dry Apricot with an
expiration date of 12/2013 stamped on the side.
No illnesses have been reported to date in connection with this problem.
The recall was initiated after routine sampling by NY State Agriculture & Markets
inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of
sulfites in the 0.50 lbs. package of dried apricots which were not declared on the label.
Subsequently, investigation indicated the problem was caused by a temporary breakdown in
the company's production and packaging processes. Production of the product has been
suspended until the company is certain that the problem has been corrected.
The consumption of 10 mg of sulfites per serving has been reported to illicit severe
reactions in some asthmatics.
Consumers who have purchased 0.50 lbs. packages of Aahu Barah brand "Dry Apricot" are
urged to return them to the place of purchase for a full refund. Consumers with questions
may contact the company at 1-516-396-0710 or 1-646-235-4154.
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Feb. 1, 2010
FDA Announces Safety Risk Associated with HIV Drug
The U.S. Food and Drug Administration announced on January 29 that non-cirrhotic portal
hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients
taking Videx/Videx EC (didanosine).
Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a
delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination
with other antiretroviral medicines to treat HIV infection in children and adults.
During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to
the FDA's Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients
died from bleeding or liver failure after developing the condition.
Non-cirrhotic portal hypertension occurs when blood flow in the portal vein - a major vein
in the liver - slows down and leads to severely enlarged veins in the esophagus. These
enlarged veins, called esophageal varices, are thin and can break open, resulting in
serious, and potentially fatal, bleeding.
The Videx and Videx EC product labels have been revised to help ensure that health care
professionals and patients are aware of the risk and the signs and symptoms of
non-cirrhotic portal hypertension.
The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain
patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not
cure HIV infection, may not prevent development of HIV-related illnesses, and may not
prevent the spread of HIV to other people.
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Feb. 1, 2010
List of Retail Stores for Sausage Recall
FSIS has reason to believe that the following retail location(s) received ready-to-eat
varieties of Italian sausage products, including salami/salame, that have been recalled by
Daniele International Inc. This list may not include all retail locations that have
received the recalled product or may include retail locations that did not actually
receive the recalled product. Therefore, it is important that you use the product-specific
identification information, available at
http://www.fsis.usda.gov/News_&_Events/ Recall_006_2010_Release/index.asp, in addition
to this list of retail stores, to check meat or poultry products in your possession to see
if they have been recalled.
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