Source: DGNews  |  Posted 3 years ago

SCOTTSDALE, Ariz -- May 19, 2008 -- Medicis is voluntarily recalling 2 lots of the antibiotic minocycline HCl, sold as Solodyn Extended Release tablets, 90 mg. The lot numbers -- B080037 (Exp: 12/09) and B080038 (Exp: 12/09) -- include 30-count bottles (NDC 99207-461-30). Medicis has received a report that 1 bottle in lot number B080037 contains azathioprine tablets (Azasan) 75 mg (NDC 65649-231-51) instead of Solodyn Extended Release tablets, 90 mg.

Azathioprine is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking azathioprine instead of minocycline presents a health hazard and safety risk to patients. Side effects associated with the use of azathioprine, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting, and diarrhoea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events.

Solodyn Extended Release is manufactured by AAIPharma, Inc. under contract to Medicis. The 2 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 AM to 11 PM 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.

Healthcare 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.

SOURCE: US Food and Drug Administration