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June 30, 2010
Texas Firm Recalls Cervelat Sausage Product
San Antonio Packing Company, a San Antonio, Texas, establishment, is recalling
approximately 9,408 lbs. of Cervelat Summer Sausage because it may contain an undeclared
allergen, milk, the U.S. Department of Agriculture's Food Safety and Inspection Service
(FSIS) announced today. The recalled products do not have an ingredients statement. The
product contains milk, a known potential allergen, which is not declared on the label.
The following products are subject to recall:
- 16 oz. packages of "APCO BRAND MEATS CERVELAT SUMMER SAUSAGE." Each package bears
the establishment number "EST. 602" inside the USDA mark of inspection and a sell-by
date up to Sept. 22, 2010.
These products were produced on various dates from April 14, 2010, through
June 22, 2010, and were distributed to retail establishments in South Texas.
When available, the retail distribution list(s) will be posted on
FSIS' Web site.
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 Bobby
Castaneda at (210) 224-5441.
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|
Source:
* FSIS Recalls, Current Recalls and Alerts, June 30, 2010.
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June 30, 2010
Beef Stroganoff with Noodles Recalled
Oregon Freeze Dry, Inc. an Albany, Ore., establishment is recalling approximately 600
pounds of Beef Stroganoff with Noodles due to a mislabeling of individual pouches that
were packed with Lasagna with Meat Sauce. The products subject to recall include:
- 4.06-ounce pouches of "Mountain House Pro-Pak Beef Stroganoff with Noodles"
Each package bears the USDA mark of inspection "Est. 1394" as well as a "Best Use By"
date of Feb 2017. Each package also has "EASY TO PREPARE" instructions on the back of
the label. The products were produced on February 1, 2010, and were distributed
nationwide on the wholesale and retail level as well as internet sales.
The problem was discovered by a consumer complaint to the establishment.
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.
Media questions regarding the recall should be directed to the company's Assistant to
the President, Becky Boyer at (541) 926-6001, Ext. 525. Consumers with questions about
the recall should contact the company's Retail Sales Manager, Melanie Cornut at
(541) 926-6001, Ext. 794.
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|
Source:
* FSIS Recalls, Current Recalls and Alerts, June 30, 2010.
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June 30, 2010
Class 2 Drug Alert - Phenindione 25 mg Tablets
Goldshield Pharmaceuticals
Phenindione 25 mg Tablets
PL 10972/0038
|
| Batch Number |
Expiry Date |
Pack Size |
First Distributed |
| 68162 |
Feb 2012 |
1x28 |
03 Jun 2010 |
|
Goldshield Pharmaceuticals is recalling the above batch because some tablets within
the batch are showing a dark orange/brown discolouration. The tablets are normally
green. The cause of the discolouration is under investigation.
Since Goldshield Pharmaceuticals is the single source of this product, there may be
supply issues. This is at present being addressed by the Company.
For medical information enquiries, please contact Goldshield Medical Information on
08700 703033,
medicalinformation@goldshieldgroup.com.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by
copy of this letter. Primary care trusts are asked to forward this to relevant clinics,
general practitioners and community pharmacists.
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|
Source:
* MHRA, United Kingdom, June 30, 2010.
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|
June 28, 2010
Class 4 Drug Alert - Acetylcysteine 200 mg/ml Injection
Aurum Pharmaceuticals Limited
Acetylcysteine 200mg/ml Injection
PL 12064/0026
|
| Batch Number |
Expiry Date |
Pack Size |
First Distributed |
| 80455 |
01 Oct 2010 |
10 x 10ml |
12 Nov 2008 |
| 90114 |
30 Jun 2011 |
10 x 10ml |
13 Aug 2009 |
|
Aurum Pharmaceuticals Limited has informed us that the two affected batches were
packed in Martindale Pharma livery. In addition, the expiry date for batch 90114
has been corrected to 30 Jun 2011.
Aurum Pharmaceuticals Limited has informed us that black particles have been found in
a very small number of ampoules from the above batches. Investigation has confirmed
that the particles comprise carbonised material which forms if droplets of solution
are present during sealing of the ampoules. Particles may be suspended in the solution,
or may adhere to the inner wall of the ampoule neck in which case they may not be
dislodged by shaking.
In order to avoid stock shortages, these batches are not being recalled. Provided
this product is inspected as per normal parenteral practices, any affected ampoules
should be detected and discarded.
For medical information enquiries please contact Aurum Pharmaceuticals Limited medical
information on 01708 382791.
|
|
Source:
* MHRA, United Kingdom, June 28, 2010.
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June 28, 2010
Nationwide Recall of Magic Power Coffee Dietary Supplement
INZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC. of Brooklyn, NY announced today that it
is conducting a voluntary nationwide recall of the dietary supplement product sold
under the name, Magic Power Coffee.
The Company has been informed by representatives of the Food and Drug Administration
(FDA) that lab analysis of one lot of the product by the FDA found that the product
contains undeclared hydroxythiohomosildenafil, similar in structure to Sildenafil, an
FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making
Magic Power Coffee an unapproved drug. The hydroxythiohomosildenafil drug ingredient is
not listed on the product label.
Hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs
such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with
diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Magic Power Coffee is distributed nationwide on Internet sites and online auctions by
multiple independent distributors participating in an online multi-level marketing
program. It is sold in a 2-serving box with UPC 718122686872 and a 12-serving carton
containing six 2-serving boxes with UPC 718122686773. All production dates up until
05/08/2010 are being recalled.
To date, no illnesses have been reported to the company or the FDA in connection with
this product.
Customers who have this product in their possession should stop using it immediately
and contact their physician if they have experienced any problems that may be related
to taking this product.
Consumers should return any unused product to the place of purchase for full refund
or contact INZ Distributors Inc./Magic Power Coffee Inc. at (718) 313-1579, Monday –
Friday, 10 am to 6 pm EDT, for further instructions.
|
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 28, 2010.
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June 26, 2010
Recall: BBQ Chicken Pizza Products That May Contain Foreign Materials
Great Kitchens, Inc., a Romeoville, Ill., establishment, is recalling approximately
109,800 pounds of BBQ chicken pizza products that may contain foreign materials,
the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS)
announced today. The following products are subject to recall:
- 14-pound, 4-ounce cases of "MARKETSIDE, 16" BBQ CHICKEN PIZZA, 8-16" Pizzas,"
bearing case codes of "11016611," "11016621," "11016711," or "11016721."
- 28.5-ounce "Marketside™, 16" BBQ RECIPE, Thin Crust, CHICKEN PIZZA."
Each box bears the establishment number "P-2539B" inside the USDA mark of inspection.
The BBQ chicken pizza products were produced on June 15 and 16, 2010, and were shipped
to distribution centers and retail stores nationwide.
The company discovered small pieces of plastic during production of 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 and media with questions about the recall should contact company President
and CEO Gerald Coghlan at (815) 306-7171.
|
|
Source:
* U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS),
June 26, 2010.
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June 25, 2010
P&G Voluntarily Recalls 4 Hour Decongestant Nasal Spray in the United States
The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling its
4-Hour Decongestant Nasal Spray. The product was distributed nationwide in the United
States.
The company said it is taking this voluntary precautionary step after finding that
the product formulation may not meet the expiration dates on the package. This recall
is not a result of consumer complaints.
P&G is removing the product in question from store shelves. Consumers who have
product with the UPC codes listed below and marked with an expiration date prior to
June 2013 should simply discard the affected product. For further information on
the product being recalled or to request a replacement coupon or refund call P&G
toll-free at 877-340-8853 (Hours of operation: Monday - Friday, 9AM - 6PM US ET,
Saturday, 10AM – 3PM US ET). The product name is:
VapoSpray 4 Hour Nasal Spray by Sinex with a UPC code of 3 23900 00082 7. Prior to
June 2009, this product was also sold as Sinex Nasal Spray in both a spray (UPC Code
3 23900 00082 7) and Ultra Fine Mist package (UPC Code 3 23900 00085 8).
Anyone experiencing an adverse reaction or quality problem with this or any
medication should consult a health care professional and notify the FDA's MedWatch
Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers
Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
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|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 25, 2010.
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June 25, 2010
Kellogg Recalls 4 cereals For Odor, Off Flavor
Working in consultation with the United States Food and Drug Administration (FDA),
Kellogg Company is implementing a voluntary recall of certain breakfast cereals
due to an uncharacteristic off-flavor and smell coming from the liner in the package.
Only products with the letters "KN" following the Better If Used Before Date are
included in the recall. Products with a "KM" designation are NOT included in the
recall. In addition, no products in Canada are affected.
Kellogg's Apple Jacks
- UPC 3800039136 1: 17 ounce package with Better if Used Before Dates between
APR 10 2011 and JUN 22 2011
- UPC 3800039132 3: 8.7 ounce packages with Better if Used Before Dates between
JUN 03 2011 and JUN 22 2011
Kellogg's Corn Pops
- UPC 3800039109 5: 12.5 ounce packages with Better if Used Before Dates between
MAR 26 2011 and JUN 22 2011
- UPC 3800039111 8: 17.2 ounce packages with Better if Used Before Dates between
MAR 26 2011 and JUN 22 2011
- UPC 3800039116 3: 9.2 ounce packages with Better if Used Before Dates between
APR 05 2011 and JUN 22 2011
Kellogg's Froot Loops
- UPC 3800039118 7: 12.2 ounce packages with Better if Used Before Dates between
MAR 26 2011 and JUN 22 2011
- UPC 3800039120 0: 17 ounce packages with Better if Used Before Dates between
MAR 26 2011 and JUN 22 2011
- UPC 3800039125 5: 8.7 ounce packages with Better if Used Before Dates between
MAR 26 2011 and JUN 22 2011
Kellogg's Honey Smacks
- UPC 3800039103 3: 15.3 ounce packages with Better if Used Before Dates between
MAR 26 2011 and JUN 22 2011
While the potential for serious health problems is low, some consumers are sensitive
to the uncharacteristic off-flavor and smell and should not eat the recalled
products because of possible temporary symptoms, including nausea and diarrhea.
No other Kellogg's products are part of this recall. The recalled products
were distributed nationwide.
"We apologize to our consumers and our customers and are working diligently to ensure
that the affected products are rapidly removed from the marketplace," said David
Mackay, president and chief executive officer, Kellogg Company.
Those with questions or who would like a replacement may contact the Kellogg
Consumer Response Center at 888-801-4163 from 8 am to 8 pm Eastern time.
|
|
Source:
* Kellogg Company, June 25, 2010.
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June 25, 2010
Recall of product MONTEVERDI/LED CARLO/GAINING PRICE/DIA Mozzarellas
Product recalled by:
CIPF-Codipal
Mark:
MONTEVERDI/LED CARLO/GAINING PRICE/DIA
Product:
Mozzarellas
Reason for the recall:
Abnormal blue color related to the presence of the bacterium "pseudomonas"
Extra informations:
The bacterium "pseudomonas" can be dangerous for the elderly or if the immune
system is weakened.
Consuming contact:
Tel.: 03 87 21 81 20
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|
Source:
* rappelsproduits.fr, June 25, 2010.
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June 25, 2010
Recall: Fresh Spinach with Best Enjoyed By Dates of June 19 to June 27, 2010
Lancaster Foods, LLC is voluntarily recalling fresh Spinach with the Best Enjoyed
By dates of 19 JUN 10 through 27 JUN 10 sold under the brand names Krisp-Pak,
Lancaster Fresh, Giant, and America's Choice because they could be contaminated
with Listeria monocytogenes. The recall extends only to products with this Use-by
Date or Product Code and sold in the following states: New Jersey, Delaware,
Pennsylvania, Maryland, North Carolina, and Virginia. No other Lancaster Foods,
LLC products are included in the recall.
The recall notification is being issued out of an abundance of caution based on a
random sample test conducted by the North Carolina Department of Agriculture Food &
Drug Protection Division (NCAGR) on fresh Spinach with the Best Enjoyed By dates of
23 JUN 10 sold under the brand name Krisp-Pak that was confirmed positive for
Listeria monocytogenes in NCAGR labs. No illnesses have been associated with this
possible contamination.
Although healthy individuals may suffer only short-term symptoms such as high
fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria M.
infection can cause serious and sometimes fatal infections in young children, frail, or
elderly people, and others with weakened immune systems. It can also cause miscarriages
and stillbirths among pregnant women. Consumers with any of these symptoms should
consult their health care provider.
Because it is still possible that the spinach with the Best Enjoyed By dates of
19 JUN 10 through 27 JUN 10 sold under the brand names Krisp-Pak, Lancaster Fresh,
Giant or America's Coice could be on store shelves, this recall extends to retailers
as well as consumers. Lancaster Foods, LLC believes that it is important to alert
consumers who might still possess one of the potentially affected expired packages of
spinach to immediately dispose of it.
Spinach included in the recall notification includes the items listed in the table
below with Best Enjoyed By dates of 19 JUN 10 through 27 JUN 10.
Instructions for Consumers:
Check your refrigerator for packaged fresh Spinach with the Best Enjoyed By dates of
19 JUN 10 through 27 JUN 10 sold under the brand name Krisp-Pak, Lancaster Fresh,
Giant, or America's Choice. The Use-by Date is found on the front of the package
in the upper right hand corner.
Consumers who may have potentially affected product are asked to empty the contents
of the package into your garbage, save the package, and contact a Lancaster Foods, LLC
consumer representative toll-free at (800) 247-8125 between the hours of 8:00 am
to 5:00 pm.
Complete Listing of Recalled Lancaster Foods, LLC spinach packed under the
Krisp-Pac, Lancaster Fresh, Giant, and America's Choice brands, Use-by Dates and
Product Codes.
|
| Bag UPC Code |
Product Description |
Oz |
| 33383 |
65201 |
Krisp-Pak Hydro-Cooled Fresh Spinach, Best Enjoyed by 19 JUN 10
thru 27 Jun 10 |
10 oz |
| 13055 |
01145 |
Lancaster Fresh, Triple Washed, All Natural, Curly Leaf Spinach,
Best Enjoyed by 19 JUN 10 thru 27 JUN 10 |
8, 10, and 12 oz |
| 88267 |
09813 |
Giant, Fresh Spinach, Best Enjoyed by 19 JUN 10 thru 27 JUN 10 |
10 oz |
| 54807 |
76060 |
America's Choice, Spinach, Cold Water Washed, Best Enjoyed by 19
Jun 10 thru 27 Jun |
10 oz |
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 25, 2010.
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June 25, 2010
Gluten Free Molasses Licorice Recalled
Name of Product:
Orgran Gluten Free Molasses Licorice 200g
Package Description & Size::
200g plastic package
Identification:
Best Before: 31 October 2011
Distribution:
Selected supermarkets and health stores throughout New Zealand. Made in and supplied
from Australia to NZ and other countries.
Reason for Recall:
Undeclared Allergen - Gluten
Comments:
Orgran Gluten Free Molasses Licorice (Orgran Natural Foods) 200g displaying Best
Before 31 October 11 should not be consumed due to the presence of undeclared
allergen gluten.
There have been no reports of illness, however any person concerned about their
health should seek medical advice.
Customers should return this product to their retailer for a full refund or phone
Crombie and Price Ltd on 3 434 8311 with any queries.
Crombie & Price Ltd
5 Torridge Street, Oamaru 9400
Phone: 03 434 8311
|
|
Source:
* New Zealand Food Safety Authority, Recalled Food Products, June 25, 2010.
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June 24, 2010
Illinois Firm Recalls Imported Beef Products Due to Potential Animal Drug Contaminant
Sampco, Inc., a Chicago, Ill., establishment is recalling approximately 61,000 pounds
of cooked canned and frozen beef products that may contain the animal drug Ivermectin,
the U.S. Department of Agriculture's Food Safety and Inspection Service announced
today.
On May 14, 2010, FSIS issued Recall News Release FSIS-RC-033-2010, a Class II recall
with low health risk, which also announced the agency was taking a number of actions
regarding lots of cooked beef from Brazil after the agency found that they may contain
the animal drug Ivermectin. Ivermectin is a broad-spectrum antiparasitic and is used
as a de-worming agent in live animals. FSIS routine point of entry testing had
discovered samples of cooked beef product from Brazil that were produced on January 20,
2010, that exceeded the tolerance level established by the U.S. Department of Health
and Human Services' Food and Drug Administration in beef muscle. While that product
was not permitted entry into the U.S., FSIS subsequently determined that associated
product may have entered the country separately, resulting in today's recall.
Based on Brazil's voluntary suspension of export for cooked beef products, FSIS
has broadened its ongoing investigation. FSIS may take further regulatory action
as it continues its investigation.
FSIS is also alerting consumers although the agency has received no reports of illness
or adverse reactions due to consumption of these products. Anyone concerned about
an illness should contact a physician. Consumers who have purchased any of these
products should return them to their point of purchase. The following products
are subject to recall
- 12 oz. cans of "Deltina CORNED BEEF WITH JUICES" with the production code
"100120" inkjetted on the top of the can. These products were sent to a
distribution center in Florida for retail sales.
- 12 oz. cans of "Hormel CORNED BEEF WITH NATURAL JUICES" with the production
code "100120" inkjetted on the top of the can. These products were sent to
distribution centers in Guam for retail sales.
- 35 lb. boxes of frozen "SEASONED COOKED BEEF." These products were distributed
to federal establishments for further processing.
- 35 lb. boxes of "Sampco Brand FROZEN COOKED BEEF, Salt Added." These products
were distributed to federal establishments for further processing.
Each product package bears "BRASIL 337 S.I.F," as well as "Product of Brazil"
or "Packed under Brazilian Government Inspection." The products subject to recall
were produced in Brazil on January 20, 2010.
Media and consumer questions regarding the recall should contact the company
hotline at (800) 685-6328.
|
|
Source:
* U.S. Department of Agriculture's Food Safety and Inspection Service, June 24, 2010.
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June 24, 2010
EH Booth and Co. Ltd withdraws Chateau Ducla French AC Bordeaux Superior
Product:
Chateau Ducla French AC Bordeaux Superior
Product Identification:
Product: Chateau Ducla French AC Bordeaux Superior 2005 and 2006 vintage.
Size: 75cl
Batch Numbers:
- 2005: 08HO8 – L5184050-44990
- 2006: 09HO9 – L5184060-50498
Risk:
The above product contains sulphites that are not declared on the label, making this
product a potential risk to consumers who are sensitive to sulphites.
Action taken by the company:
EH Booth and Co Ltd has withdrawn the affected batch from sale. In addition, the company
has contacted the relevant allergy support organisations, which will inform their at
risk members of the withdrawal. Notices will be displayed in all stores to alert consumers
to the reasons for the withdrawal and the actions they can take if they have purchased
the product. A copy of the notice can be viewed via the link below. No other EH Booth and
Co Ltd products are known to be affected.
Advice to Consumers:
Customers with a sensitivity to sulphites are advised not to drink this product.
|
|
Source:
* Food Standards Agency, United Kingdom, June 24, 2010.
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June 24, 2010
Class 4 Drug Alert: Aurum Pharmaceuticals Limited - Acetylcysteine 200mg/ml Injection
Aurum Pharmaceuticals Limited
Acetylcysteine 200mg/ml Injection
PL 12064/0026
|
|
Batch Numbers:
|
Expiry Dates:
- 1 October 2010
- 30 June 2011
|
Pack Sizes:
|
First Distributed:
- 12 November 2008
- 13 August 2009
|
|
Aurum Pharmaceuticals Limited has informed us that black particles have been found in a
very small number of ampoules from the above batches. Investigation has confirmed that
the particles comprise carbonised material which forms if droplets of solution are
present during sealing of the ampoules. Particles may be suspended in the solution, or
may adhere to the inner wall of the ampoule neck in which case they may not be dislodged
by shaking.
In order to avoid stock shortages, these batches are not being recalled. Provided
this product is inspected as per normal parenteral practices, any affected ampoules
should be detected and discarded.
For medical information enquiries please contact Aurum Pharmaceuticals Limited
medical information on 01708 382791.
|
|
Source:
* MHRA, Safety Warnings, Drug Alerts, United Kingdom, June 24, 2010.
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June 23, 2010
St. John Ambulance Australia Inc. Survival Saline Solution Recalled
Product Description:
Survival Saline solution 15 ml
Identifying Features:
Supplied in the following St John First Aid Kits purchased during September 2009 -
December 2009
Leisure Small - Batch SJ0902
Leisure Medium - Batch SJ0903
Leisure Large Batch - SJ0904
Lot 20090715, ARTG no. 155522
Hazards:
Illness or mistreatment
Defects:
This batch of Survival Saline solution has been found to be contaminated and may
cause infection.
Product Sold:
Dates Available for Sale:
September 2009 - December 2009
Supplier:
St John Ambulance Australia Inc.
What Should Consumers Do?
If you have any vials of Survival 15ml Saline Solution (Batch 20090715) DO NOT
USE IT. Please destroy the vials and you will be sent replacements. Please call
Customer Service on: 1300 598 829 or (02) 8788 1362
|
|
Source:
* Product Safety Recalls, Australia, June 23, 2010.
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June 23, 2010
South Gate Meat Co. Recall: Ground Beef Products Due To Possible E. coli Contamination
South Gate Meat Co., a South Gate, Calif., establishment, is recalling approximately
35,000 pounds of ground 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 products subject to recall include:
- 20, 30 and 40 pound bulk packages of "SOUTH GATE MEAT CO. GROUND BEEF."
- 30, 40, and 50 pound bulk packages of "SOUTH GATE MEAT CO. COARSE GROUND BEEF."
- 10 and 20 pound packages of "SOUTH GATE MEAT CO. GROUND BEEF PATTIES."
Each package bears establishment number "EST. 6217" inside the USDA mark of
inspection. These ground beef products were produced between the dates of June 7,
2010, through June 21, 2010, and were shipped to restaurants in the Los Angeles
and Orange County, Calif. area.
The problem was discovered through FSIS microbiological sampling which confirmed
a positive result for E. coli O157:H7. FSIS and the company have 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.
Media and consumer questions regarding the recall should be directed to the
company's owner, John Dritsas and the company's Vice President, Angelo Dritsas
respectively at (323) 564-1701.
|
|
Source:
* U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS),
June 23, 2010.
|
|
|
|
June 22, 2010
Recall: Ground Beef Products Due To Possible E. coli Contamination
Crown I Enterprises, Inc., a Bay Shore, N.Y., establishment, is recalling
approximately 3,700 pounds of ground 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 products subject to recall include:
- 24, 8-ounce burgers in 12-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED,
BURGER FRESH, WB HOME STYLE 8 OZ."
- 32, 6-ounce burgers in 12-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED,
BURGER FRESH 6 OZ."
- 48, 4-ounce burgers in 12-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED,
BURGER FRESH, 4 OZ."
- 10-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BEEF GROUND/EXTRA LEAN."
- 10- and 20-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BEEF GROUND 80/20."
Each package bears establishment number "EST. 20889" inside the USDA mark of
inspection as well the Julian dates of "10164" and "10166." These ground beef
products were produced on June 11, 2010, and June 15, 2010, and were shipped to
food service institutions in Conn., N.J., and N.Y.
The problem was discovered through FSIS microbiological sampling which confirmed a
positive result for E. coli O157:H7. FSIS and the company have 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.
Media and consumer questions regarding the recall should be directed to the
company's Vice President of Operations, Kevin Peterson, at (631) 289-8401, ext. 2222.
|
|
Source:
* U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS),
June 22, 2010.
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|
June 18, 2010
Orgran Gluten Free Molasses Licorice Recalled
Product Description:
Package Description: Plastic pouch (resealable)
Package Size: 200g
Country of Origin: Australia
Identifying Features:
Date Marking: Best before: 31 Oct 11
Hazards:
Illness
Defects:
Labelling – Undeclared allergen (gluten)
Product Sold:
Traders who Sold Product:
The products have been on the market place for nine weeks, (Distributed from the
warehouse 15th April 2010). This product is distributed to small businesses, health
food stores and specialty stores.
Supplier:
Roma Food Products
What Should Consumers Do?
Return to place of purchase for full refund
|
|
Source:
* Product Safety Recalls, Australia, June 18, 2010.
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June 18, 2010
Solomon Kosher Butcher Pty Ltd Premium Beef Mince Recalled
Product Description:
Premium beef mince (diet beef mince) purchased on 16th June 2010 or 17th June, 2010.
All weights, no printed package – sold loose and for immediate use (customers told
to consume immediately or freeze within 24h of purchase).
Country of Origin: Australia
Hazards:
Illness
Defects:
Foreign matter – rubber washing-up glove
Product Sold:
VIC
Traders who Sold Product:
Café D'Lish on Bambra, Daneli's Deli, Eshel Take Away, Kleins Kosher
Gourmet, Myflame Restaurant and Sue Kluwgant.
Supplier:
Solomon Kosher Butcher Pty Ltd
What Should Consumers Do?
Return the product to the point of purchase with proof of purchase for immediate
full cash refund.
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|
Source:
* Product Safety Recalls, Australia, June 18, 2010.
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June 18, 2010
Iowa Firm Recalls Frozen Chicken Products Due To Possible Salmonella Contamination
ConAgra Foods Packaged Foods, LLC, a Council Bluffs, Iowa establishment is
recalling Marie Callender's brand Cheesy Chicken and Rice
frozen meals, the U.S. Department of Agriculture's Food Safety and
Inspection Service (FSIS) announced today.
The company is recalling all Marie Callender's brand Cheesy Chicken and Rice frozen
meals in commerce, regardless of production date. These products are being recalled
after the company was informed by the U.S. Centers for Disease Control and
Prevention (CDC) of an investigation involving 29 people in 14 states who have been
diagnosed with salmonellosis linked to Salmonella serotype Chester. Eight of the
case-patients specifically reported eating this product in April and May, 2010,
prior to illness onset; the last reported illness was reported on May 22.
- 13-ounce packages of "Marie Callender's Cheesy Chicken & Rice White Meat
Chicken and Broccoli over Rice Topped with Rich Cheddar Sauce."
Each package bears a label with establishment number "P-45" inside the USDA mark
of inspection. The establishment is recalling all the products listed above which
are currently in commerce. These products were distributed to retail establishments
nationwide. When available, the retail distribution list(s) will be posted
on FSIS' Web site.
FSIS became aware of the problem during the course of an ongoing investigation of a
multi-state outbreak of Salmonella serotype Chester illnesses. CDC, the Food and Drug
Administration (FDA), FSIS, and state health and agriculture departments are cooperating
in this ongoing investigation. The investigation is ongoing, and has not yet definitively
identified a food vehicle(s). Further information will be released to the public as it
becomes available.
Consumers with questions about the recall should contact ConAgra Foods at
1-866-484-9610. Media questions regarding the recall should be directed to
Teresa Paulsen, Vice President of Communications and External Relations at
(402) 240-5210.
Consumption of food contaminated with Salmonella can cause salmonellosis, one of
the most common bacterial foodborne illnesses. Salmonella infections can be
life-threatening, especially to those with weak immune systems, such as infants, the
elderly, and persons with HIV infection or undergoing chemotherapy. The most common
manifestations of salmonellosis are diarrhea, abdominal cramps, and fever within
eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting
that can last up to seven days.
|
|
Source:
* FSIS, News Releases, June 18, 2010.
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June 18, 2010
Texas Firm Recalls Three Varieties of Spaghettios With Meatballs
Campbell Soup Supply Company, LLC, a Paris, Texas, establishment is recalling
approximately 15,000,000 pounds of "SpaghettiOs with Meatballs" canned products due to
possible under-processing, the U.S. Department of Agriculture's Food Safety and
Inspection Service (FSIS) announced today. The following products are subject to
recall:
- 14.75-ounce cans of "SpaghettiOs" with Meatballs, bearing the identifying
product code "U5" on the bottom of the can.
- 14.75-ounce cans of "SpaghettiOs" A to Z with Meatballs, bearing the
identifying product code "4N" on the bottom of the can.
- 14.75-ounce cans of "SpaghettiOs" Fun Shapes with Meatballs (Cars), bearing
the identifying product code "KS" on the bottom of the can.
The products subject to recall bear the establishment number "EST 4K," as well as a
"Use By" date between June 2010 and December 2011 ink-jetted on the bottom of each
can. These products were manufactured between December 2008 and June 2010 and
distributed to retail establishments nationwide.
RETAIL DISTRIBUTION LIST.
The problem was discovered through a routine warehouse inspection by the company and
its subsequent investigation. FSIS has received no reports of illnesses from
consumption of these products.
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 questions regarding the recall should be directed to Campbell's Hotline
at (866) 495-3774; media inquiries should be directed to the company's Director of
Corporate Communications, Anthony Sanzio at (856) 968-4390.
|
|
Source:
* FSIS, News Releases, June 18, 2010.
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June 17, 2010
Recall: Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots
as an addition to the list of products included in the company’s January 15th, 2010
product recall. The additional lots involved are:
- Four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count,
sold in the U.S.
- One product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in
the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico
|
| Product Name |
Product Form |
Lot Number |
NDC Number |
UPC Code |
| BENADRYL Allergy ULTRATAB Tablets 100 count |
Ultratab Tablet |
AJA008, ADA194, ABA022, ABA264 |
50580-226-10 |
312547170338 |
| EXTRA STRENGTH Tylenol Rapid Release Gels 50 count |
Rapid Release Gelcap |
ASA202 |
50580-488-50 |
300450488503 |
|
This recall is a follow-up to the product recall that McNeil Consumer Healthcare
announced on January 15th, 2010 and is being taken because the products were
inadvertently omitted from the initial recall action. McNeil Consumer Healthcare
identified the omission and informed the U.S. Food and Drug Administration (FDA) of its
decision to add these product lots to the recall list. All these products were produced
before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has
continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that
information with the FDA. This further analysis confirms that the risk of serious
adverse medical events is remote. This recall is being conducted with the knowledge
of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated
for the relief of allergy associated symptoms such as sneezing, runny nose, itchy
throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is
sold over-the-counter and is indicated for the temporary reduction of fever and for
the temporary relief of minor aches and pains due to headache, muscular aches,
backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual
cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a
musty or moldy odor that has since been linked to the presence of trace amounts of a
chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was
determined that the source of TBA was the result of a breakdown of a chemical that is
applied to wood used to build wooden pallets that transport and store product packaging
materials.
Consumers who purchased product from the lots included in this recall should stop using
the product and contact McNeil Consumer Healthcare for instructions on a refund or
replacement. For these instructions or information regarding how to return or dispose of
the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or
call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9
a.m. to 5 p.m. Eastern Time).
Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at
1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD
20852-9787, or on the MedWatch website.
The product lot numbers for the recalled products can be found on the side of the
bottle label.
|
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 17, 2010.
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June 17, 2010
Recall: All Jacobs Well Egg Farm Eggs
Product Information:
Cardboard egg cartons and catering packs
Country of Origin: Australia
Identifying Features:
APN/EAN/TUN NUMBER:
Medium 500g 9332022005000
Large 600g 9332022006007
Extra Large 700g 9332022007004
Jumbo 800g 9332022008001
Hazard:
Illness
Defects:
Microbial - Salmonella
Where Product Was Sold:
QLD
Supplier:
Jacobs Well Egg Farm
Traders Who Sold Product:
The affected product has been distributed to Rocklea Markets, IGA stores, Foodlink and
corner stores in South East Queensland and has been on the market for 3 to 4 weeks.
Advice to Consumers:
Return to place of purchase for full refund.
|
|
Source:
* Product Safety Recalls, Australia, June 17, 2010.
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June 17, 2010
Recall: Asda Indian Tikka Masala & Jalfrezi Meal for 2
Product Information:
Asda Indian Tikka Masala & Jalfrezi Meal for 2
Pack size: 1.37kg
Use by: 20 June 2010
Risk:
Due to a packaging error, the above product has been packed with a Korma meal instead
of the Tikka Masala & Jalfrezi meal and therefore contains cashew nuts. The presence
of undeclared cashew nuts poses a public health risk to those allergic to nuts. The
allergen advice box does include a 'may contain traces of nut' warning but does not
declare the presence of nuts.
Action By Company:
The company has withdrawn the affected product and has contacted the relevant allergy
support organisations, which will inform their at-risk members of the withdrawal.
Notices are being displayed in all stores to alert consumers to the reasons for the
withdrawal and the actions they can take if they have purchased the product. A copy
of the point-of-sale notice issued by Asda can be viewed via the link below. No
other Asda products are known to be affected.
Advice to Consumers:
Customers with an allergy to nuts are advised not to eat this product.
|
|
Source:
* Food Standards Agency, United Kingdom, June 17, 2010.
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|
June 16, 2010
Recall: Hovis Hearty Oats Loaf Due to Potential Glass Contamination
Product Information:
Hovis Hearty Oats Loaf, 800g
All loaves with a best before date, up to and including 20 June 2010.
Risk:
A small number of the above product potentially contain small pieces of glass.
Action By Company:
The company has recalled the affected product from consumers. The company has placed a
Press Recall Statement in several national publications on 16 June, explaining to
customers the reason for recall and the actions they can take if they have bought the
affected product. No other Hovis products are known to be affected.
Advice to Consumers:
If you have purchased a Hovis Hearty Oats Loaf with a best before date code of the
20 June or earlier, please do not consume the product. For refund information please
refer to the
company's recall notice.
|
|
Source:
* Food Standards Agency, United Kingdom, June 16, 2010.
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June 15, 2010
Recall: Cooked, Frozen Claw Island Brand, Craig's All Natural Brand and Inland Ocean Brand Lobster Claw and Knuckle Meat Because of Possible Health Risk
Portland Shellfish Company, Inc. is voluntarily recalling the following brands of
cooked, ready to eat fresh or frozen lobster meat: Portland Shellfish Co. Inc brand,
Claw island, Craig's All Natural, and Inland Ocean cooked, fresh or frozen lobster
claw and knuckle meat as recent tests show the product 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 infection can cause miscarriages and stillbirths among pregnant
women. The recalled products were distributed nationwide in wholesale and retail
stores.
- LOBSTER CLAW & KNUCKLE MEAT, CS 6 x 2 LB, packed under the Claw Island, Craig's All
Natural or Inland Ocean brand, production lot numbers 13210, 13310, and 13410, shipped
between 05/14/2010 and 05/26/2010.
-
LOBSTER KNUCKLE MEAT, CS 6 x 2 LB, packed under the Inland Ocean brand, production lot
numbers 13210, shipped on 05/13/2010.
-
LOBSTER CLAW & KNUCKLE MEAT, CS 18 x 15 oz, packed under the Claw Island brand,
production lot numbers 13210 and 13410, shipped between 05/25/2010 and 06/08/2010.
-
LOBSTER CLAW & KNUCKLE MEAT, CS 20 x 8 oz, packed under the Craig's All Natural brand,
production lot numbers 13210, shipped on 05/14/2010.
-
LOBSTER KNUCKLE MEAT, 1 LB bag, fresh, packed under Portland shellfish brand,
production lot number 13310, shipped on 05/12/2010.
-
LOBSTER CLAW & KNUCKLE MEAT, 4 oz bag, fresh, packed under Portland shellfish brand,
production lot number 13310, shipped on 05/13/2010.
-
LOBSTER CLAW & KNUCKLE MEAT, 1 LB bag, fresh, packed under Portland shellfish brand,
production lot number 13210 and 13310, shipped on 05/12/2010 and 05/13/2010.
-
LOBSTER CLAW & KNUCKLE MEAT, 2 LB bag, fresh, packed under Portland shellfish brand,
production lot number 13210 and 13310, shipped on 05/12/2010 05/13/2010, 05/14/2010.
-
LOBSTER CLAW & KNUCKLE MEAT, 5 LB bag, fresh, packed under Portland shellfish brand,
production lot number 13210, shipped on 05/12/2010.
Consumers who have purchased these products are urged not to consume it and to
return the product to the place of purchase for a full refund. Consumers with
questions may contact the company at 207-699-5505, Monday through Friday between
8:00 a.m to 5:00 p.m No related foodborne illnesses have been reported to date.
|
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 15, 2010.
|
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|
June 15, 2010
Undeclared Sulfites in Strawberry Farms Sun Dried Tomatoes
Sirob Imports, Inc. of Lindenhurst, NY, is recalling 16 oz vacuum packed bags of
Strawberry Farm Sun Dried Tomatoes because they contain undeclared sulfites. Consumers
who have severe sensitivity to sulfites run the risk of serious or life threatening
allergic reactions if they consume this product.
The product comes in 16 oz, clear plastic vacuum packed bags. The recalled Strawberry
Farm Sun Dried Tomatoes were distributed in Queens, NY to a retail store.
The recall was initiated after routine sampling by New York State Department of
Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory
personnel revealed the presence of sulfites in the 16 oz vacuum packed bags Strawberry
Farm Sun Dried Tomatoes which were not declared on the label. The consumption of 10
milligrams of sulfites per serving has been reported to elicit severe reactions in some
asthmatics. Anaphylactic shock could occur in certain sulfites sensitive individuals
upon ingesting 10 milligrams or more of sulfites. Analysis of the Strawberry Farms
Sun Dried Tomatoes revealed they contained 197 milligrams per 4 oz serving.
No illnesses or allergic reactions involving this product have been reported to date.
Consumers who have purchased 16 oz vacuum packed bags Strawberry Farm Sun Dried
Tomatoes are urged to return them to the place of purchase for a full refund.
Consumers with questions may contact the company at 631-957-8888.
|
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 15, 2010.
|
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|
June 11, 2010
Morrisons Chicken Chow Mein Recalled
Product Information:
Morrisons Chicken Chow Mein, 400g
Use by: 12 June 2010
Description: Black filmed tray with cardboard sleeve
Risk:
Due to a packaging error, a very small number of packs actually contain Morrisons
Chicken Fried Rice. As a result, the presence of egg and milk are not declared on the
label. Therefore, this makes the product a potential health risk for people who are
allergic to egg or allergic/intolerant to milk or milk constituents.
Action By Company:
The company has recalled the affected product and has contacted the relevant allergy
support organisations, which will inform their at-risk members of the recall. Notices
are being displayed in all stores to alert consumers to the reasons for the recall
and the actions they can take if they have purchased the products. A copy of the
point-of-sale notice issued by Wm Morrison Supermarkets is attached to this Allergy
Alert. No other Wm Morrison Supermarkets products are known to be affected.
Advice to Consumers:
Customers with an allergy to egg and/or an allergy/intolerance to milk or milk
constituents are advised not to eat this product.
|
|
Source:
* Food Standards Agency, United Kingdom, June 11, 2010.
|
|
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|
June 11, 2010
Recall: Madelaine Gummy Baby Crocodiles Day Old Chicks and Gummy Coral Fish
Product Information:
Brand Name: Madelaine Gummy Baby Crocodiles, Madelaine Gummy Day Old Chicks and Madelaine
Gummy Coral Fish
Package Description: Plastic jar
Package Size: 140g
Country of Origin: Vietnam
Best Before: 20/04/12, Batch Number 20/04/10J12
Hazards:
Illness
Defects:
Foreign matter - metal pieces
Product Sold:
National
Traders Who sold Product:
Woolworths/Safeway
Supplier:
Madelaine Confectionery Pty Ltd
Advice to Consumers:
Return to place of purchase for a full refund.
|
|
Source:
* Product Safety Recalls, Australia, June 11, 2010.
|
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|
June 8, 2010
Undeclared sulphur dioxide in Tree of Life Dried Apricots
Product:
Tree of Life Dried Apricots
Risk:
The above product contains sulphur dioxide that is not declared on the label, making
this product a potential risk to consumers who are sensitive to sulphites.
Product Identification:
Product: Tree of Life Dried Apricots
Size: 1kg packs, 12.5kg, 125kg, 250kg, 500kg
Batch number/date codes: All product to be removed from sale
Action taken by the company:
The company has contacted all of its customers, advising them of the need to remove the
product from sale until it is over-labelled with the correct ingredients information.
The company has notified the relevant allergy support organisations who will contact
there at-risk members. No other Tree of Life Ltd brand products are known to be
affected.
Advice to Consumers:
Customers with a sensitivity to sulphites are advised not to eat this product.
|
|
Source:
* Food Standards Agency, United Kingdom, June 8, 2010.
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|
June 8, 2010
Co-operative Recalls 4 Types of Wine
The Co-operative has recalled some 75cl bottles of wine from customers because the
products might contain small pieces of glass. The Agency has issued a Product Recall
Information Notice.
Details of the four types of wine being recalled and the affected lot codes can be
found below. Each lot code, which appears on the label on the back of the bottle,
begins with the letter 'L' and is followed by five numbers.
- Co-operative Californian The Pink Chill Zinfandel Rose, 75cl
- L10120, L10126, L10127, L10128, L10130, L10131, L10132 and L10144
- Co-operative Californian The Fab Cab Ruby Cabernet Shiraz, 75cl
- L10132 and L10133
- Co-operative Californian The Big Chill Colombard Chardonnay, 75cl
- L10119, L10120, L10134, L10137 and L10138
- Silver Creek Sauvignon Blanc, 75cl
- L10133 and L10134
Product recall notices have been displayed in stores that sell the product, explaining
why the products have been recalled and how customers can get a full refund. If you
have bought any of the affected wine, you can contact The Co-operative by calling
freephone 0800 0686 727 for a full refund. No other Co-operative products are known
to be affected.
|
|
Source:
* Food Standards Agency, United Kingdom, June 8, 2010.
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|
June 7, 2010
Eastern Fish Recalls Hannaford and Bloom Private Brand Frozen Raw Extra Jumbo Shrimp
Teaneck, N.J. Eastern Fish is alerting consumers that Hannaford Supermarkets and
Bloom brands of frozen raw extra jumbo (16/20) shrimp in 16 oz packages, as well as
these brands of shrimp from the full-service seafood cases, labeled as product of
Mexico, sold May 4 through June 4 at Hannaford Supermarkets and sold April 8 through
June 4 at Bloom grocery stores, are subject to a voluntary recall because the products
may contain undeclared sulfites. People who have an allergy or sensitivity to sulfites
risk an allergic reaction if they consume these products.
To date, the company has received no reports of adverse reaction associated with
these products. Customers are asked to return any Hannaford or Bloom brands of frozen
16/20 shrimp products to their store for a full refund if the Hannaford or Bloom
frozen extra jumbo shrimp product of Mexico were purchased from Hannaford Supermarkets
or Bloom grocery stores during the specified timeframes.
These products were distributed to Hannaford stores and to independent stores serviced
by Hannaford in:
- New York
- Massachusetts
- New Hampshire
- Vermont
- Maine
and to Bloom stores in:
- North Carolina
- South Carolina
- Virginia
- Maryland
The recall was initiated after Bloom was notified by the North Carolina Department of
Agriculture that test results from routine product sampling indicated the presence of
sulfites in the shrimp. Eastern Fish is cooperating fully with the FDA.
Product Description
- Hannaford Raw Shrimp Extra Jumbo E-Z Peel Shrimp, 16-20 shrimp per pound,
(UPC code: 04126813037) (product of Mexico). With the following
datescodes:PGC33509,PGC33609,PGC33709,PGC33809,PGC34109
- PGC34209
- Bloom Private Brand Frozen Raw Extra Jumbo Shrimp (UPC code: 72543990374) (product
of Mexico).with the following dates codes:PGC33109,PGC33409,PGC33509
- The products come in 16 oz. bags.
Consumers who have purchased these products during the specified timeframes may
return them to any Hannaford or Bloom store for a full refund.
|
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 7, 2010.
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June 7, 2010
Recall of All Lots of Ondansetron in 5% Dextrose Injection, 32 mg/50 mL
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all
lots of:
- Ondansetron injection in 5% dextrose 32mg / 50 mL (NDC number 25021-776-50)
Manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being
recalled are:
- A090309
- A090310
- A090311
- A090312
Which were distributed to hospitals, wholesalers and distributors nationwide from August
2009 through May 2010. Ondansetron injection is an intravenous product used to treat
nausea and vomiting associated with chemotherapy or surgery and is supplied in a single
dose plastic container.
Sagent has initiated this voluntary recall of ondansetron to the user level in
conjunction with Claris Lifesciences' recall due to the discovery of foreign material
and non-sterility in one lot of ondansetron injection. Non-sterility of an antiemetic
administered via the intravenous route has the potential to result in infections,
which could be fatal, especially in patients who are immunocompromised. Sagent is not
aware of any adverse patient events resulting from this product and is continuing its
diligent investigation of the situation. Consumers should contact their physician or
healthcare provider if they have experienced any problems that may be related to taking
or using this product. This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
Customers have been instructed to examine their inventory immediately and to
quarantine, discontinue distribution of and return all recalled lots of the
product. Customers who may have further distributed this product have been requested
to identify their customers and notify them at once of this product recall. The
necessary form by which to document this information as well as other information
regarding this recall is available at www.SagentPharma.com1. Any questions about
returning unused product should be directed to the customer call center at (866)
625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about
ondansetron injection may contact Sagent Medical Affairs (866-625-1618 option 3).
|
|
Source:
* FDA, Market Withdrawals, & Safety Alerts, June 7, 2010.
|
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June 3, 2010
Parents Reminded: 'Honey is not suitable for babies'
The Food Standards Agency is reminding parents not to feed honey to babies who are
under a year old. This follows a case of the rare but serious illness, infant botulism.
There have only been 11 confirmed cases of infant botulism in the past 30 years, but
three of these have occurred in the past year and all have had possible links to honey.
The most recent case involved a 15-week-old baby.
Honey is safe for children over the age of one, but a younger baby's gut is not
sufficiently developed to be able to fight off the botulism bacteria. This is why
parents are advised not to give babies honey until they are one year old.
Sam Montel, nutritionist at the Food Standards Agency, said: 'For around the first
six months babies only need breast milk or infant formula and although it might be
tempting to give honey to your baby to ease coughs, infant botulism is a very serious
illness and it simply isn't worth the risk.
'Once introduced to solid foods, it's always best to avoid sweetening your baby's food
or giving them sugary snacks and drinks, this will help stop them developing a sweet
tooth and tooth decay.'
|
|
Source:
* Food Standards Agency, United Kingdom, June 3, 2010.
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June 3, 2010
Update on Products Free of Colours Associated with Hyperactivity
The Agency has updated its list of product ranges that do not contain the six food
colours associated with possible hyperactivity in young children. Another
manufacturer producing product lines free of the colours has been added to the
list: Candyking Ltd's Candyking products.
The list includes companies whose product ranges have never contained the six colours
and companies whose product ranges that have been reformulated to remove the colours.
The colours, identified by a Southampton University study financed by the Food
Standards Agency, are:
- sunset yellow FCF (E110)
- quinoline yellow (E104)
- carmoisine (E122)
- allura red (E129)
- tartrazine (E102)
- ponceau 4R (E124)
The Agency is publicising the product ranges to encourage the food industry to
participate in the voluntary ban. The voluntary ban was agreed by Ministers in
November 2008.
Consumers who are particularly concerned about the presence of the colours should
continue to check labels, especially in the case of products with a long shelf-life,
where the availability of reformulated products may vary.
Any food manufacturer, retailer or caterer wishing to notify the Agency that their
brands or products are free of these colours, should email the details to Benedict
Duncan, at
benedict.duncan@foodstandards.gsi.gov.uk.
|
|
Source:
* Food Standards Agency, United Kingdom, June 3, 2010.
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June 3, 2010
OM Fusion Removed from the Canadian Market
The Issue:
Following a February 2010 Advisory concerning unauthorized products sold under the
OM Fusion Distributors LLC label, additional unauthorized products with the OM Fusion
label have been removed from the Canadian market by Health Canada.
The labels for Valocormid and Voltaren indicate the products contain ingredients
that legally require the products to be sold by prescription because they are used to
treat serious diseases or may have side effects that require monitoring by a health
care practitioner. Additional unauthorized OM Fusion health products were sold in
Canada with packaging in Russian, Ukrainian or Kazakh languages only. As a result,
important information about the proper use and potential side effects of these products
may not be understood by consumers.
What Consumers Should Do:
Consult your healthcare practitioner if you have used any of these products and are
concerned about your health.
Read the labelling of the products you buy to verify that they have been assessed by
Health Canada for safety, effectiveness and quality. Health products that have been
authorized for sale by Health 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.
Background:
The ingredients listed on the label of the Valocormid and Voltaren products can
cause serious health problems. If you have taken products containing these
ingredients without the supervision of a health care practitioner or without a
prescription you may face additional risks. You may be misdiagnosed, the treatment
might not be appropriate to treat your illness and you may miss the opportunity to
obtain appropriate medical treatment. You may also put yourself at risk for
drug interactions, or harmful side effects.
For More Information:
Consumers and health professionals wanting more information about this advisory from
Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free
at 1-866-225-0709. Media enquiries related to this Advisory should be directed to
Health Canada Media Relations at 613-957-2983.
|
|
Source:
* Health Canada, Advisories, Warnings & Recalls, June 3, 2010.
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June 2, 2010
Ciprofloxacin, Metronidazole and Ondansetron Recalled
Claris Lifesciences today announces the voluntary nationwide recall of all lots of:
- Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24)
- Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC 36000-009-24)
- Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24)
- Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06)
Manufactured and distributed by Claris Lifesciences. All lots are being recalled, which
were distributed to hospitals, wholesalers and distributors nationwide.
Claris has initiated this voluntary recall of the product listed above to the user level
as a precautionary measure against possible contamination due to packaging integrity of
the product. Claris is initiating a voluntary recall of the products listed above
because it has received reports of floating matter which may pose risk if administered
to patients. Healthcare professionals should NOT use these products, and should
immediately remove them from their pharmacy inventories. This recall is made with the
full knowledge of the Food and Drug Administration. Claris is not aware of any adverse
patient events resulting from this product and is continuing its diligent investigation
of the situation.
Customers have been instructed to examine their inventory immediately and to quarantine,
discontinue distribution of and return all recalled lots of the product. Customers who may
have further distributed this product have been requested to identify their customers and
notify them at once of this product recall. The necessary form by which to document this
information as well as other information regarding this recall is available at
http://www.clarislifesciences.com/Claris_USA/index.asp. Any questions
about returning unused product should be directed to the customer call center at +1 (877)
725- 2747, M-F 8am-7pm CST. Healthcare workers who have medical questions about the
products may contact the same number and ask for Medical affairs.
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Source:
* FDA, Market Withdrawals, & Safety Alerts, June 2, 2010.
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June 2, 2010
Class 2 Drug Alert: Gabapentin 100mg Capsules
Product Description:
Ranbaxy (UK) Limited
Gabapentin 100mg Capsules
PL 14894/0530
Batch #:
2037862
Expiry Date:
May 2011
First Distributed:
10 Sep 2009
Comments:
Ranbaxy (UK) Limited is recalling all unused stock of the above batch because the patient
information leaflet (PIL) has not been updated to include safety warnings initiated by the
European Medicines Agency. The missing text should be positioned under the heading 'Take
special care with' and states the following:
'A small number of people being treated with anti-epileptics such as Gabapentin have had
thoughts of harming and killing themselves. If at any time you have these thoughts,
immediately contact your doctor'
For any stock enquiries please contact Ranbaxy (UK) Limited on 0208 742 5299. For medical
information enquiries, please contact Ranbaxy (UK) limited on 0208 742 5292.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy
of this letter. Primary Care Trusts are asked to forward this to relevant clinics, General
Practitioners and Community Pharmacists.
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Source:
* MHRA, Safety Warnings, Drug Alerts, June 2, 2010.
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June 1, 2010
Allergy Alert: Bluebird Light Plus Potato Chips
Product Description:
Bluebird Light Plus Sea Salt Potato Chips 150g
Identification:
Best Before: 25 August 2010
NZ Distribution:
Supermarkets and Dairy's throughout the North Island.
Reason for Recall:
Undeclared Allergens - Milk, Soy & Gluten
Comments:
Bluebird Light Plus Sea Salt Potato Chips (150g bags) displaying Best Before date 25
August 2010 should not be consumed due to the presence of undeclared allergens – milk,
soy and gluten.
There have been no reports of illness, however any person concerned about their health
should seek medical advice.
Customers should return this product to their retailer for a full refund or phone
Bluebird Foods Ltd on 0800 762 324 with any queries.
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Source:
* Food Safety Authority, New Zealand, June 1, 2010.
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