Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is issuing a Drug Recall for one lotâ€”Lot # 284081â€”of JantovenÂ® Warfarin Sodium, USP, 3mg Tablets. This is an anticoagulant with an expiration date of September 2012, NDC # 0832-1214-00.
Upsher-Smith Laboratories initiated the recall after a single bottle labeled as JantovenÂ® 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 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 optimal care for many ill patients. For this reason, patientsâ€™ doses must be adjusted by regular measurements of the degree of anticoagulation 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 health care provider regarding the appropriateness of their current therapy prior to making any change.
The two Jantoven tablets can be readily identified by color: The 3mg tablet is tan and the 10mg tablet is white. The 3mg tablet is also 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.
The defective drug 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 Upsher-Smith medical information line at 1.888.650.3789, Monday-Friday between 8:00 a.m. and 5:00 p.m., Central Standard Time.
Adverse reactions may be reported to the Food & Drug Administration’s (FDA) MedWatch Adverse Event Reporting program either online, by regular mail or by fax.