Thread: Fda recalls - 2012

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

ZIP INTERNATIONAL GROUP LLC, Issues An Alert On Listeria In Sliced Herring Fillet In Oil (Forelka)

Contact:
Consumer:
732-225-3600

Media:
Leon Nagel
732-225-3600

FOR IMMEDIATE RELEASE - January 10, 2012 - ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6 Edison, NJ 08837 is recalling Sliced herring fillet (Forelka) due to Listeria contamination.
Listeria is a common organism found in nature. It can cause serious complications for pregnant women, such as stillbirth. Other problems can manifest in people with compromised immune systems. Listeria can also cause serious flu-like symptoms in healthy individuals.
The recalled Sliced herring fillet (Forelka) comes in both 330 gram and 600 gram plastic containers with a code date of best before 03/06/2012. They were sold in the New York Metropolitan Area. It is a product of Ukraine.
The recall was initiated after routine sampling by New York State Department of Agriculture & Markets Food Inspectors & subsequent analysis of the product by Food Laboratory personnel found the product to be positive for Listeria monocytogenes.
No illnesses have been reported to date in connection with this problem. Consumers who have purchased Sliced herring fillet (Forelka) should not consume it, but should return it to the place of purchase. Consumers with questions may contact the company @ 732-225-3600.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

ZIP INTERNATIONAL GROUP LLC, Issues An Alert On Listeria In Sliced Herring Fillet In Oil (Forelka)

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

D.F. Stauffer Biscuit Co., Inc. Issues Allergy Alert and Voluntary Recall on Safeway Snack Artist Sugar Free Bite-Sized Chocolate Chip Cookies Due to Mislabeling and Undeclared Allergens

Contact:
Consumer:
888-480-1988

FOR IMMEDIATE RELEASE – January 4, 2012 – D. F. Stauffer Biscuit Co., Inc. is voluntarily recalling one specific lot of Safeway Snack Artist Sugar Free Bite-Sized Chocolate Chip Cookies because they contain undeclared milk and eggs. People with an allergy or severe sensitivity to milk or eggs run the risk of serious or life-threatening allergic reactions if they consume this product. Symptoms may include itching, hives, wheezing, vomiting, anaphylaxis and digestive problems, such as bloating, gas or diarrhea. No illnesses have been reported to date.

The recall affects only Safeway Snack Artist Sugar Free Bite-Sized Chocolate Chip Cookies bearing the Best By date of 07-11-12 and Lot # L07112B packaged in 10 oz clear plastic tubs and sold in Safeway, Carrs, Dominick's, Genuardi's, Pak 'N Save, Pavilions, Randalls, Tom Thumb and Vans. The Best By date and Lot Number are printed on the product lid.

The products were distributed across the United States. No other lots or products are affected. The recall was initiated after it was discovered that the incorrect rear label was applied to the container and the presence of the milk and eggs was not declared. Consumers who have purchased the recalled product are urged to return it to the place of purchase for a full refund.

Consumers with questions may contact D.F. Stauffer Biscuit Co., Inc at 888-480-1988.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

D.F. Stauffer Biscuit Co., Inc. Issues Allergy Alert and Voluntary Recall on Safeway Snack Artist Sugar Free Bite-Sized Chocolate Chip Cookies Due to Mislabeling and Undeclared Allergens

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Bedford Laboratories Issues Guidance On 2011 Voluntary Recall Of Polymyxin B For Injection USP And Vecuronium Bromide For Injection Related To Glass Particles

Contact:
Consumer:
800.562.4797

Media:
Jason Kurtz
440.201.3668
jason.kurtz@boehringer‐ingelheim.com

FOR IMMEDIATE RELEASE - January 10, 2012 - Bedford Laboratories today issued updated guidance on the following nationwide voluntary product recalls originally issued on August 2, 2011:

Polymyxin B for Injection USP, 500,000 Units per vial – NDC #55390-139-10
Lot 1942980 – Exp. Date August 2013 and Lot 1895027 – Exp. Date June 2013
Vecuronium Bromide for Injection, 10 mg per vial – NDC #55390-037-10
Lot 1865067 – Exp. Date May 2012
Vecuronium Bromide for Injection, 20 mg per vial – NDC #55390-039-10
Lot 1865069 – Exp. Date February 2012

The recalls were initiated on August 2, 2011 after the discovery of a visible glass particle in a limited number of vials within the lots listed above to the user level.

Particulate matter in injections can be harmful when introduced into the bloodstream. Potential adverse events after intravenous administration may include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death. The introduction of particulate matter via the intrathecal route into the cerebrospinal fluid may serve as a nidus for the development of chemical meningitis. Introduction of a foreign body to the eye via topical or subconjuntive routes can cause corneal abrasion/laceration, lacrimal tear and general irritation. To date, there have been no reports of adverse events for the lots being recalled.

Polymyxin B is indicated in the treatment of acute infections caused by susceptible strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.

Vecuronium Bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Initial recall notification of the Polymyxin B for Injection and Vecuronium Bromide for Injection lots listed above were sent to impacted wholesalers and distributors on August 2, 2011 by overnight courier and arranged for return of all recalled product. Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed above for patient care and should immediately quarantine any product for return. Should wholesalers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800.562.4797.

Bedford Laboratories has informed the U.S. Food and Drug Administration (FDA) of its actions and is maintaining ongoing discussion with the agency. This voluntary recall is being conducted with the knowledge of the FDA.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers, or patients with product quality compliance, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 800.521.5169. Any adverse reactions experienced with any of the lots reported in this release should be also reported to 800.521.5169.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm1
Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm2. Mail to address on the pre-addressed form.
Fax: 1.800.FDA.0178
As is standard practice, and as stated in the Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

About Bedford Laboratories

Bedford Laboratories is located in Bedford, OH and began in 1993 as a division of Ben Venue Laboratories. Bedford Laboratories supplies an extensive selection of critical-care and medically necessary multisource and specialty injectable products to the healthcare marketplace. For more information, please visit http://www.BedfordLabs.com3.

About Ben Venue Laboratories, Inc.

Ben Venue Laboratories, Inc. was founded in 1938 and is a leading manufacturer of highly complex, sterile injectable drug products for the global pharmaceutical industry. Ben Venue is located in Bedford, Ohio and employs more than 1,300 people. For more information, visit www.benvenue.com4.

Ben Venue is a U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies. Please visit http://us.boehringer-ingelheim.com5.
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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Bedford Laboratories Issues Guidance On 2011 Voluntary Recall Of Polymyxin B For Injection USP And Vecuronium Bromide For Injection Related To Glass Particles

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Blount Fine Foods Announces Rip Roar'N Crab Soup Recall For Undeclared Milk, Wheat And Crab Allergens

Contact:
Consumer:
1-800-274-2526

Media:
Larry Marchese
LegionThirteen
(617) 733-8899
lmarchese@legionthirteen.com

FOR IMMEDIATE RELEASE - January 11, 2012 - Blount Fine Foods of Fall River, MA is recalling a single date code of Blount Fine Foods branded Rip Roarin’ Crab Soup in 16 ounce retail cup pack size because of undeclared milk, wheat and crab allergens. People who have an allergy or severe sensitivity to milk, wheat or crab run the risk of suffering serious or life-threatening reactions if they consume this product.

Product:
Blount Fine Foods branded Rip Roarin’ Crab Soup 16oz retail cup
Product Code: 71116 Lot Number: 1202117D Use or Freeze By: 2/10/2012

The Rip Roarin’ Crab Soup back label incorrectly identifies the product as Manhattan Clam Chowder and the ingredient statement does not declare the allergens-milk, wheat or crab.

The lot code and sell by date are printed in black ink on the bottom of the cup.

No other products or date codes are affected by this recall.

The product was distributed to select Whole Foods Retail stores on the Eastern Coast of the United States

No illnesses have been reported to date.

Consumers who have purchased item listed above with affected lot number are urged to return it to the place of purchase for a full refund. Consumers who have health-related concerns should contact their physician. Consumers with questions may contact the Blount Fine Foods at 1-800-274-2526, Monday – Friday, 8 a.m.-5 p.m. Eastern Time. Additional information is available at www.blountfinefoods.com1

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Blount Fine Foods Announces Rip Roar'N Crab Soup Recall For Undeclared Milk, Wheat And Crab Allergens

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Gilster-Mary Lee, Corp. Announces Recall Of Hill Country Fare Brand Of Lasagna Dinner Mix Due To The Presence Of Undeclared Soy

Contact:
618-826-2361 ext. 3283

FOR IMMEDIATE RELEASE - January 12, 2012 - The following Recall has been announced.

Hill Country Fare Lasagna Dinner

DETAILS: Gilster-Mary Lee of Chester, IL is recalling some packages of dry lasagna dinner mix. The only brand involved is Hill Country Fare 6.4 oz. Lasagna Dinner which has a Best By date of NOV 21 12 Y18. (UPC# 41220-78102) Consumers should return to store for full refund.

WHY: A Creamy Noodle Tuna Helper seasoning pouch was found in a carton that should have had a Lasagna flavored seasoning pouch. The tuna pouch has a Soy (allergen) ingredient not present in the Lasagna seasoning. People who have allergies to Soy may run the risk of an allergic reaction if they consume this product.

INCIDENTS: No illnesses have been reported in connection with this dinner mix.

HOW MANY: As many as 8,376 cartons (698 cases) may have been affected.

FOR MORE INFORMATION: Call the company at 618-826-2361 ext. 3283 from 8:00 am to 4:30 pm CST

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Gilster-Mary Lee, Corp. Announces Recall Of Hill Country Fare Brand Of Lasagna Dinner Mix Due To The Presence Of Undeclared Soy

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Herbadashery LLC Issues Allergy Alert on Undeclared Anchovy in Pine Ridge BBQ and Dipping Sauce and Pine Ridge Jalapeño BBQ and Dipping Sauce

Contact:
Consumer:
1-307-265-0036

FOR IMMEDIATE RELEASE - December 28, 2011 - Herbadashery LLC, Casper, WY is recalling bottles of Pine Ridge BBQ and Dipping Sauce and Pine Ridge Jalapeño BBQ and Dipping Sauce manufactured after January 1, 2011 because they contain undeclared anchovies in the Worcestershire sauce used in production. People who have allergies to anchovies run the risk of serious or life threatening allergic reaction if they consume these products.

The recalled Pine Ridge BBQ and Dipping Sauce and Pine Ridge Jalapeño BBQ and Dipping Sauce were distributed through retail internet sales and in retail stores from January 1, 2011 to September 1, 2011.

The products come in 18 oz. or 34 oz. glass bottles and plastic gallon bottles. Products are coded by lot #’s 10111 through 90111 on the bottom of each bottle. These bottles DO NOT have an add on sticker reading CONTAINS ANCHOVIES. Additionally, these products are not identified with UPC codes.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after an onsite FDA inspection on 11/23/11revealed that anchovies were contained in the Worcestershire sauce used in production of these products and labeling did not reveal the presence of anchovies.

Consumers who have purchased Pine Ridge BBQ and Dipping Sauce or Pine Ridge Jalapeño BBQ and Dipping Sauce containing these codes or have these products that do not have the CONTAINS ANCHOVIES sticker on them, are urged to return them to the place of purchase. Consumers with questions may contact Herbadashery LLC at 1-307-265-0036 between the hours of 10 am and 6 pm MST.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Herbadashery LLC Issues Allergy Alert on Undeclared Anchovy in Pine Ridge BBQ and Dipping Sauce and Pine Ridge Jalapeño BBQ and Dipping Sauce

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Price Chopper Supermarkets Issues Volunatry Stuffed Clam Recall (Schenectady, N.Y.)

Contact:
Consumer:
Price Chopper
1-800-666-7667

Media:
Mona Golub
Price Chopper
518-379-1480
monag@pricechopper.com

Jon Pierce, APR
Pierce Communications
518-221-1186
jon@albanypr.com

FOR IMMEDIATE RELEASE - January 3, 2012 -rice Chopper Supermarkets is issuing a voluntary recall on 'Gourmet Stuffed Clams' from its seafood departments with a scale code of 209181. This product is being recalled due to the fact that it contains milk, wheat and eggs, three known allergens, which are not listed on the store generated ingredient label.

The stuffed clams were sold chain wide in Price Chopper seafood departments between September 30 and December 30. The label was updated on December 30 to correctly reflect all of the ingredients contained in the product.

In addition to alerting the media, Price Chopper has initiated its Smart Reply notification program, which uses purchase data and consumer phone numbers on file in connection with the company's AdvantEdge (loyalty) card to alert those households that may have purchased the product in question.

Customers can return the product to their local Price Chopper for a full refund. For more information, visit the pricechopper.com1 2website or call Price Chopper at 1-800-666-7667, option 3 between the hours of 8:30am and 7:00pm.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Price Chopper Supermarkets Issues Volunatry Stuffed Clam Recall

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http://www.alipac.us/f19/fda-fines-r...0/#post1251358

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Rexall Issues Allergy Alert on Undeclared Shellfish in Calcium 1200mg plus Vitamin D 1000 IU Softgels

Contact:
Consumer
1-888-534-6370

Media
Brian Ellis
804-675-8140

FOR IMMEDIATE RELEASE - January 16, 2012 - Today Rexall, Inc., of Deerfield Beach, Florida, announced a recall of Rexall Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels. The affected bottles actually contain a TABLET product, Triple Strength Glucosamine Chondroitin and MSM Tablets.

Glucosamine is derived from the shells of certain crustaceans. Because the product may contain trace quantities of undeclared shellfish, people who have an allergy or severe sensitivity to shellfish (e.g., shrimp, crab, lobster, clams or oysters) run the risk of serious or life-threatening allergic reaction if they consume this product.

Rexall Calcium 1200 mg plus 1000IU Vitamin D3 was distributed solely at Dollar General, which has 9,800 stores across 38 states. This recall involves only one lot number, 387651-04.

Product # Description UPC Code Label Expiration Date Lot Number
45211 Rexall Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels 3 01220 45211 3 Rexall 08/15 387651-04

To date, no adverse events have been reported related to this product.

When customers complained about the finding tablets in the bottle, and the discrepancy was confirmed, Rexall immediately began the recall process and removed the product from store shelves. Rexall is conducting an internal review of the manufacturing process to determine how the product was mislabeled.

Consumers who have this product in their possession can return it to Dollar General for a full refund or contact Rexall at 1-888-534-6370.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Rexall Issues Allergy Alert on Undeclared Shellfish in Calcium 1200mg plus Vitamin D 1000 IU Softgels

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Minnesota Firm Issues Recall Due to Undeclared Soy Allergen in Certain Sunflower Seeds

Contact:
Consumer:
1-866-209-0985.

Media:
Phone: 952-469-1417
Fax: 952-469-9517

FOR IMMEDIATE RELEASE - January 12, 2012 – Ryt-way Industries LLC is voluntarily recalling select sunflower seeds because they may contain soy ingredients that were not declared on the packaging. The recall is being issued on BIGS ® Dill Pickle Sunflower Seeds packaged in 5.35oz plastic bags with BEST BY Dates of 08DEC2012 and 09DEC2012 with an individual bag UPC code 896887002202. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

The product was distributed nationwide through supermarkets, convenience stores and U.S. military commissaries.

No illnesses have been reported to date.

The recall was initiated after it was discovered that product containing soy was distributed in packaging that did not reveal the presence of soy.

Consumers who are allergic to soy and who have purchased the recalled products are advised not to consume the product and are urged to return it to the place of purchase for a full refund. Consumers with questions may contact 1-866-209-0985.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Minnesota Firm Issues Recall Due to Undeclared Soy Allergen in Certain Sunflower Seeds