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Upsher-Smith expands nationwide voluntary recall of tablets

Upsher-Smith Laboratories, a Minnesota-based pharmaceutical company, is voluntarily expanding its previously announced recall of Jantoven Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between 17 May 2010 and 17 November, 2010.

Jantoven (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors.

The recall was initiated as a precautionary measure after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3 mg Tablets was found to contain tablets at a higher, 10 mg strength.

The expanded recall (affected products) includes Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol and Oxybutynin.

Since the affected products were distributed to wholesalers, retail chains and independent pharmacies throughout the US, Upsher-Smith is working cooperatively with the US Food and Drug Administration to quickly notify its pharmacy customers and wholesalers, and arrange for the return of all recalled products.

The products were packaged at the Upsher-Smith plant in Plymouth, Minnesota.