FDA NEWS

Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16)
Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg.

Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12)
Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate.

Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and Relenza
Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients...

Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27)
As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems.

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.

Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15)
Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN.

FDA Requests Recall of Xiadafil VIP Tabs
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects.

Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes
Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi...

Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter
FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ...