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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 AZASANŽ instead of SOLODYNŽ 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: 7/16/2008 Reason: A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Distribution: Nationwide Date: 6/12/2008 Reason: it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil Distribution: Nationwide Date: 6/16/2008 Reason: Oversized tablets may contain as much as two times the labeled level of active morphine sulfate Distribution: Nationwide Date: 6/12/2008 Reason: Oversized tablets may contain as much as two times the labeled level of active morphine sulfate Date: 7/15/2008 Reason: Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. Distribution: Nationwide Date: 8/7/2008 Reason: The product contains potentially harmful, undeclared ingredients. Distribution: Nationwide |
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