Solodyn Recall: Bottles May Contain a Different Medication

On Monday, the FDA announced a recall for certain lots of Solodyn Extended Release Tablets since they could contain the wrong medication. Individuals who filled a prescription for the antibiotic Solodyn (minocycline), may have actually received bottles containing Azasan (azathioprine), an immunosuppressant. This could pose a severe safety risk to consumers.

The Solodyn recall applies to 90 mg, 30-count bottles (NDC 99207-461-30) of the extended release tablets from lot numbers B080037 and B080038. Both lots contain an expiration date of December 2009, and were manufactured in February 2008. The medication is sold by Medicis and manufactured under a contract with AAIPharma, Inc.

Solodyn is an antibiotic primarily prescribed to treat acne for those 12 years of age or older. Azasan, is a potent immunosuppressive agent which is prescribed to kidney transplant patients to help prevent their body from rejecting the organ. It is also used for treatment of rheumatoid arthritis, by decreasing the effects of certain cells in the body’s immune system.

The product mix-up could expose individuals who were prescribed Solodyn to a risk of potentially severe adverse effects, especially among the elderly or those who are taking multiple medications. Common side effects of Azasan could include reduction of red and white blood cells and platelets (mylosuppression), infection, bleeding, chills, nausea, vomiting, diarrhea, joint pain and muscle pain. It could also cause severe problems if the drug causes unanticipated interactions with other drugs.

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