Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota
is voluntarily 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.  

At Upsher-Smith, patient safety is of foremost concern. 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.  

Consistent, continuous dosing of warfarin is necessary for
optimal care for many ill patients. For this reason, patients’ 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. 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.