Recall Of Jantoven Warfarin Sodium Tablets Labeled 3 mg

Washington, DC: Upsher-Smith Laboratories is recalling one lot (lot #284081) of Jantoven® Warfarin Sodium, USP, 3mg Tablets, an anticoagulant with an expiration date of September 2012, NDC # 0832-1214-00.

The company is initiating the recall as a precautionary measure after a single bottle labeled as Jantoven® Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher, 10mg strength before it was dispensed. To date, the company has identified no additional mislabeled bottles.

The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.

The two Jantoven tablets can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832.

Upsher-Smith Laboratories is working cooperatively with the U.S. Food and Drug Administration 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 United States. The company is notifying its pharmacy customers and wholesalers, and arranging for the return of all recalled product. The product was packaged at the Upsher-Smith plant in Plymouth, Minnesota.

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Published on Feb-17-11