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Voluntary Recall For Specific Lot Numbers of Solodyn® Extended Release Tablets, 90 mg

May 20, 2008

Source: Medicis and the FDA

Medicis, the manufacturers of Solodyn® Extended Release Tablets 90mg, a drug used to treat specific acne conditions in patients 12 years and older, issued a voluntary drug recall due to a product mix up.

The FDA and Medicis informed health care professionals of a recall to Solodyn® Extended Release Tablets, 90 mg, for lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09).

This product was recalled because one of the bottles in these specific lots contained Azasan® (azathioprine tablets) 75mg instead of Solodyn®. Azasan® is an immunosuppressive agent used to prevent kidney rejection in transplant patients as well as a medication used to treat rheumatoid arthritis.

Possible side effects associated with the use of Azasan®, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Additionally, joint and muscle pain also are common side effects.

Make special note of possible unanticipated interactions with other drugs which may lead to serious adverse events.
Health care professionals are urged to check their inventory and pull the referenced lot numbers of Solodyn® from their stock. Arrangements for the return of this product need to be made directly through the manufacturer.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Solodyn