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Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-UpDate: 6/12/2008
Reason: Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients
The Food and Drug Administration (FDA) released the following information:
Contact: FOR IMMEDIATE RELEASE -- SCOTTSDALE, Ariz. -- May 16, 2008 -- Medicis today 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. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events. SOLODYN® is manufactured by AAIPharma, Inc. under contract to Medicis. The two lots were manufactured during February 2008. The recall is limited to these lots, and ample supplies of SOLODYN® remain on the market. Any inquiries related to this recall should be addressed to Stericycle Customer Service at 1-888-656-6381 with representatives available Monday through Friday, 8 a.m. to 11 p.m. EST. For any medical information inquiries or to report an adverse event related to this recall, contact Medicis at 1-800-900-6389 with representatives available 24 hours a day, 7 days a week. Health care professionals may continue to prescribe the Medicis brand SOLODYN®. This recall is being conducted in cooperation with the contract manufacturer of the products and with the knowledge of the FDA. Any adverse reactions experienced with the use of this product, and/or quality problems, also may be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. SOLODYN is a registered trademark of Medicis Pharmaceutical Corporation. AZASAN is a registered trademark of AAIPharma, Inc. Type of Recall:Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. Other Drugs / Medicines Recalls and Alerts of InterestDate: 11/12/2008 Reason: Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. Distribution: Nationwide Date: 11/12/2008 Reason: These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Distribution: Nationwide Date: 10/27/2008 Reason: Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Distribution: Nationwide Date: 11/6/2008 Reason: The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. |
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