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Warfarin sodium tablets recalled
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One lot of Jantoven Warfarin Sodium, USP, 3 mg tablets with an expiration date of September 2012 was recalled as a precautionary measure after a single bottle was found to contain tablets at a higher, 10 mg strength. To date, the company has not identified additional mislabeled bottles, according to an FDA press release.
The tablets are manufactured by Upsher-Smith Laboratories, Inc. in Minnesota. The company is voluntarily recalling lot #284081 of the anticoagulant, which could cause an accidental overdose more than three-times the labeled amount, leading to excessive anticoagulation and resulting in life-threatening hemorrhage.
The two tablets can be easily identified by color: the 3 mg tablet is tan with the letters WRF, a line and the number 3 below the line; the 10 mg tablet is white with the letters WRF, a line and the number 10 below the line. The reverse side of both tablets has the number 832.
The company is cooperating with the FDA to implement a nationwide recall as quickly and efficiently as possible.
The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the US. The company is notifying its pharmacy customers and wholesalers, and arranging for the return of all recalled product.
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