February 24, 2011 – Upsher-Smith Laboratories, is voluntarily recalling one lot (lot #284081) of Jantoven Warfarin Sodium, USP, 3 mg 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, 3 mg 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 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.
Consistent, continuous dosing of warfarin is necessary for many ill patients. For this reason, patients' doses must be regularly to assure warfarin use is safe and effective. Either abrupt interruption of this medication or administration of an inappropriately high dose could present a serious health risk. Patients should check with their healthcare provider regarding the appropriateness of their current therapy prior to making any change.
The two Jantoven tablets can be readily identified by color: the 3 mg tablet is tan and the 10 mg tablet is white. In addition, 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.
The company is working cooperatively with the U.S. Food and Drug Administration (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 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.
Consumers and pharmacists can call the company’s medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).
Any adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
For more information: www.upsher-smith.com