RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS ARCHIVE FOR RECALLS, MARKET WITHDRAWALS & SAFETY ALERTS ENFORCEMENT REPORTS INDUSTRY GUIDANCE MAJOR PRODUCT RECALLS - 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 … [Read more...]
Search Results for: labeling
BYETTA Kidney Failure Risk
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 … [Read more...]
TRANS TECH ( 09V416000 )
Vehicle Make / Model: Model Year(s): TRANS TECH / MFSAB 2007-2009 Manufacturer: TRANS TECH BUS Mfr's Report Date: OCT 22, 2009 NHTSA CAMPAIGN ID Number: 09V416000 N/A NHTSA Action Number: N/A Component: EQUIPMENT:OTHER:LABELS Potential Number of Units … [Read more...]
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
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 … [Read more...]
Price Rite 25 Ct Beef Bouillon Recalled: Allergy Alert
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 … [Read more...]
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