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Warfarin recalled due to possible potency issue

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Bristol-Myers Squibb has recalled one lot of 1,000-count 5 mg warfarin sodium tablets due to the possibility that the drug may be too potent, according to a press release.

There were 1,854 bottles of 1,000 warfarin sodium (Coumadin) tablets in the recall.

The issue was discovered during testing of tablets from a returned bottle. One tablet was found to be “higher in potency than expected,” according to company officials.

The officials said other samples from the same lot met requirements for active pharmaceutical ingredient homogeneity and support product quality. However, because the company could not conclusively exclude the possibility that other tablets in the lot may fail to meet potency specifications, the recall was conducted as a precautionary measure.

Besides the recall, Bristol-Myers Squibb “has also taken additional preventive measures to further assure active pharmaceutical ingredient homogeneity and potency in the Coumadin manufacturing process,” the release said.

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