BYETTA Kidney Failure Risk
November 5, 2009
The FDA has announced labeling changes on the diabetes drug BYETTA (exenatide). The revisions will warn doctors and patients of the risk of kidney failure and renal insufficiency when taking the medication. So far there have been at least four reported deaths from kidney failure associated with BYETTA use. This is not the first significant health risk that has been linked to BYETTA. The drug has been associated with acute pancreatitis, including at least two pancreatitis-related deaths.
Curly’s Food Recalls Roast Beef Deli Products Due To Mislabeling And An Undeclared Allergen
November 5, 2009
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TRANS TECH ( 09V416000 )
November 1, 2009
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FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
October 2, 2009
The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later. This change—largely in response to the 2007-2008 heparin contamination problem—will include a new USP reference standard and test method that is used to determine the potency of the drug. The new test method, unlike the previous method, is able to detect impurities that may be present in heparin. The monograph change will also harmonize the USP unit dose with the WHO International Standard (IS) unit dose.
California Firm Recalls Sausage Products Due to Mislabeling and Undeclared Allergens
September 26, 2009
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Frick’s Quality Meats Recalls Sausage Products Due to Mislabeling
September 25, 2009
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Price Rite 25 Ct Beef Bouillon Recalled: Allergy Alert
September 25, 2009
Sept 24, 2009 – associated Brands Inc. of Medina, New York is voluntarily recalling 320 cases (3,840 selling units) of “Price Rite Beef Flavored Bouillon Cubes”, lot code 22 JUL 11, as the lot has the potential to contain a dairy allergen which is not declared on the label. Consumers who have an allergy to milk may run the risk of a serious or life-threatening allergic reaction if they consume this product.
Portex Uncuffed Pediatric-Sized Tracheal Tubes
September 22, 2009
Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009.
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
September 17, 2009
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.
AFC Trading & Wholesale Recalls AFC Beancurd Sheets and Sticks
September 16, 2009
AFC Trading & Wholesale, Inc., of Los Angeles, CA, recalls AFC Frozen Beancurd Sheets (8oz. & 16oz.) and AFC Frozen Beancurd Sticks (8oz.) because of it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses have been reported to date.
Smiths Medical Issues Urgent Device Recall Of Portex Pediatric-Sized Tracheal Tubes
September 12, 2009
Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before
September 2009.
Jaguar Recalls 34 Year 2010 XF Vehicles
August 9, 2009
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Carefusion Issues Update Regarding Previously Disclosed Recall of the Alaris
July 31, 2009
CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System:
BabySwede LLC Recalls Bouncer Chairs Due to Laceration Hazard
July 29, 2009
WASHINGTON, D.C. – THE U.S. CONSUMER PRODUCT SAFETY COMMISSION, IN COOPERATION WITH THE FIRM NAMED BELOW, TODAY ANNOUNCED A VOLUNTARY RECALL OF THE FOLLOWING CONSUMER PRODUCT. CONSUMERS SHOULD STOP USING RECALLED PRODUCTS IMMEDIATELY UNLESS OTHERWISE INSTRUCTED.
NAME OF PRODUCT: BABYBJöRN® BABYSITTER BALANCE AND BABYBJöRN® BABYSITTER BALANCE AIR BOUNCER CHAIRS
Hy-Vee Recalls Mislabeled Salad Dressing
July 3, 2009
Hy-Vee Inc. is voluntarily recalling some 12-oz. bottles of Hy-Vee HealthMarket Organic Balsamic Vinaigrette dressing. The bottles are mislabeled and actually contain Hy-Vee HealthMarket Organic Sesame Ginger Dressing.
As a result of the mislabeling, the potential exists for undisclosed ingredients that may affect allergens.
City Baking Brand Apple Crumb Cake
June 29, 2009
City Baking LLC, of Long island City, NY is recalling 781 individually wrapped City Baking brand Apple Crumb Cakes, because they contain Walnuts, which were inadvertently omitted from the label. People who have an allergy or severe sensitivity to Walnuts run the risk of serious or life threatening illness if they consume these products.
City Baking LLC
June 28, 2009
Company Contact:
Barry Blaine
718-392-8514
FOR IMMEDIATE RELEASE – June 26, 2009 – City Baking LLC, of Long island City, NY is recalling 781 individually wrapped City Baking brand Apple Crumb Cakes, because they contain Walnuts, which were inadvertently omitted from the label. People who have an allergy or severe sensitivity to Walnuts run the risk of serious or life threatening illness if they consume these products.
OKK Trading To Pay $665,000 Civil Penalty for Violating Federal Lead Paint Ban
June 26, 2009
WASHINGTON, D.C. – AS PART OF ITS COMMITMENT TO PROTECTING THE SAFETY OF CHILDREN, THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) ANNOUNCED TODAY THAT OKK TRADING, OF COMMERCE, CALIF., HAS AGREED TO PAY A $665,000 CIVIL PENALTY (PDF) FOR FAILING TO COMPLY WITH A 30-YEAR OLD BAN ON LEAD PAINT ON TOYS, AS WELL AS VIOLATING OTHER FEDERAL CHILD SAFETY STANDARDS.
Hi-Tech Pharmaceuticals Recalls All Lots of Stamina-Rx Dietary Supplement Products
June 17, 2009
Norcross, GA – Hi-Tech Pharmaceuticals, Inc. (”Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company’s product sold under the name Stamina-Rx.
CARDINAL ( 09V148000 )
May 3, 2009
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