Upsher-Smith Laboratories Expands Drug Recall on 2/18/11: Products Now Include 7 Drugs

Smith Laboratories, Inc., of Maple Grove, Minnesota is expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. Previously, a bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.

Consistent, continuous dosing of any product is necessary for optimal care for many ill patients. Patients should check with their health care provider regarding the appropriateness of their current therapy prior to making any change.

The expanded recall includes the following products: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin.

To see the full list of products (and various strengths), batch numbers, expiration dates and product identification information, click here.

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 products affected were 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 products. These products were packaged at the Upsher-Smith plant in Plymouth, Minnesota.

Consumers and pharmacists can call 1-877-492-4791 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (EST).

Any adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: http://www.fda.gov/MedWatch/report.htm

Regular: Use postage-paid, pre addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm . Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

See also by R.C. Johnson:
Jantoven Warfarin Sodium Tablets 3mg Recalled Due to Mislabeled Bottles (2/16/11)

Source: http://www.fda.gov/Safety/Recalls/ucm244111.htm