One Lot Jantoven Warfarin Sodium Tablets Recalled by Manufacturer

February 28, 2011 10:53 AM

FDA is notifying health care providers that Upsher-Smith Laboratories has recalled one lot of Jantoven^® Warfarin Sodium, USP, 3 mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3 mg Tablets was found to contain tablets at a higher 10 mg strength. To date, the company has identified no additional mislabeled bottles. The product lot was distributed to wholesalers, retail chains, and independent pharmacies throughout the US. The primary risk of substituting 10 mg warfarin for 3 mg warfarin is overdosing more than three times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.

The number of the recalled lot is 284081, with an expiration date of September 2012. The Upsher-Smith press release reminds health care providers and patients that the two Jantoven tablets can be readily identified by color: the 3 mg tablet is tan and the 10 mg tablet is white. The press release also includes a link to photographs of the 3 mg and 10 mg tablets. In addition, the manufacturer advises that the 3 mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3 mg tablet carries the number 832. The 10 mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10 mg tablet carries the number 832.