News | February 24, 2011

Voluntary Recall Issued for Jantoven Warfarin Tablets

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

Related Content

Effect of Daily Aspirin on First-Time Heart Attack and Stroke Risk Inconclusive
News | Pharmaceuticals | September 04, 2018
The jury is still out on whether people at moderate risk of a first heart attack or stroke should take daily aspirin to...
Blood Pressure and Cholesterol-lowering Drugs Continue to Improve Survival After a Decade
News | Pharmaceuticals | August 27, 2018
Blood pressure and cholesterol-lowering drugs continue to improve survival in patients with hypertension after more...
Pfizer Announces Positive Topline Results from Phase 3 ATTR-ACT Study
News | Pharmaceuticals | April 06, 2018
Pfizer Inc. announced that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study met its primary endpoint...
Humanetics Presents Data on Drug to Protect Cardiac Cells From Space-Like Radiation

Photo from NASA

News | Pharmaceuticals | February 01, 2018
February 1, 2018 –Humanetics Corporation (Humanetics) has recently completed two research studies funded by the Natio
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals | October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
News | Pharmaceuticals | October 04, 2017
October 4, 2017 — MyoKardia Inc.
News | Pharmaceuticals | September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Merck Announces Results of REVEAL Outcomes Study of Anacetrapib
News | Pharmaceuticals | September 11, 2017
Merck and researchers in the Clinical Trial Service Unit at the University of Oxford announced the publication and...
Statins Associated With Improved Heart Structure and Function
News | Pharmaceuticals | May 26, 2017
Statins are associated with improved heart structure and function, according to research presented at EuroCMR 2017, May...
Feature | Pharmaceuticals | May 16, 2017
May 16, 2017 – Results of a groundbreaking clinical trial demonstrate the effectiveness of a novel, fast-acting nasal
Overlay Init