FDA Announces Soldyn Recall Due to Azasan Product Mix-UpMay 20, 2008 | Parker Waichman LLP
The US Food and Drug Administration (FDA) just announced today that Medicis issued a voluntary recall of Solodyn®—generically known as minocycline HCL, USP—due to a product mix-up with another medication. The Solodyn® drugs involved in the recall are the 90 Mg, “Extended Release” tablets with Lot Number B080037 and expiration date Exp: 12/09 and Lot Number B080038 with expiration date Exp: 12/09. The recalled tablets were distributed in 30-count bottles (NDC 99207-461-30). This recall is being conducted in cooperation with the contract manufacturer of the products and with the knowledge of the FDA.
Medicis received a report that one bottle of Solodyn® in lot number B080037 contains a different medicine—Azasan®, known generically as azathioprine tablets—in a 75 mg (NDC 65649-231-51) dose instead of the Solodyn® (minocycline HCl, USP), Extended Release Tablets, 90 mg.
Solodyn® is an antibiotic that is part of the class of broad spectrum tetracycline antibiotics, has an even broader spectrum than other like drugs in its class, and is also considered a bacteriostatic antibiotic with higher serum levels compared to other such medications. Solodyn® is primarily used to treat acne and other skin infections, is sometimes used in the treatment of lyme disease, had been used in the treatment of Neisseria meningitides—although that use is not generally recommended due to dizziness and vertigo side effects—and may also be used to treat some strains of Methicillin-resistant Staphylococcus aureus (MRSA) infection and disease resulting from use of drug-resisitant Acinetobacter.
Conversely, Azasan® is prescribed for vastly different uses and is an immunosuppressive agent that is generally prescribed to transplant patients in order to prevent kidney rejection. Azasan® is also prescribed for use in the treatment of rheumatoid arthritis.
According to the FDA, taking Azasan® instead of SolodynN® presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan®,
particularly in the elderly, include mylosuppression—which is a 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 of Azasan®. The FDA also warns that 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 involved in the recall were manufactured during February 2008 and the recall is limited to these two lots. Sufficient Solodyn® supplies remain on the market and health care professionals may continue to prescribe the Medicis brand Solodyn®.
Consumers can direct any inquiries related to this recall to Customer Service at Stericycle. Stericycle can be reached at 1-888-656-6381, Monday through Friday, 8 a.m. to 11 p.m. EST. For medical information inquiries or to report an adverse event related to this recall, contact Medicis at 1-800-900-6389, 24 hours a day, 7 days a week. Any adverse reactions experienced with the use of this product, and/or quality problems, may also 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.