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Upsher-Smith expands recall

Upsher-Smith Laboratories is voluntarily recalling a number of products after a bottle of warfarin was found to contain tablets at a higher dosage than labelled

Upsher-Smith Laboratories is voluntarily recalling a number of its products after a single bottle of its anticoagulant warfarin was found to contain tablets at a higher dosage than labelled.

The company recently announced a nationwide recall of Jantoven (warfarin) after one bottle labelled as containing 3mg tablets was found to contain 10mg tablets. Though no adverse events were reported, any overdose based on the mislabelling could potentially lead to life-threatening haemorrhaging, according to the US Food and Drug Administration (FDA).

Upsher-Smith has now expanded the recall to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. A number of generics manufactured by the company are being recalled, including the Parkinson's disease drug amantadine; the anti-hypertensive amlodipine; the male hormone therapy androxy; the antisposmadic agent baclofen; bethanechol, which is used for difficulty in urination; and the overactive bladder therapy oxybutynin.

The products were packaged at the Upsher-Smith plant in Plymouth, Minnesota, and were distributed to wholesalers, retail chains and independent pharmacies throughout the United States.

Upsher-Smith said it is working with the FDA to implement the nationwide recall "as quickly and efficiently as possible" and is arranging for the return of all of the recalled products.

21st February 2011

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