Recall of Jantoven Warfarin Expanded to Other Upsher-Smith Drugs

A Jantoven Warfarin recall issued last week after the discovery of a mislabeled bottle, has been expanded to include other medications manufactured by Upsher-Smith Laboratories, including Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol and Oxybutynin. 

The expanded Upsher-Smith drug recall was announced on February 18, adding additional medications that were labeled on the same packaging line between May 17 and November 17, 2010. The company has said that the expansion is a precautionary measure.

Taking the wrong pill could result in consumers suffering drug overdoses, unexpected side effects, severe injury and also means that the consumer did not get the medication they were prescribed. There have been no injuries or illnesses reported in connection to mislabeled Upsher-Smith drugs.

The recall now affects 100-ct bottles of Amantadine 100 mg, 90-ct bottles of Amlodipine 5 mg, 100-ct bottles of Androxy 10 mg, 90-ct bottles of Baclofen 10 mg, 100-ct bottles of Bethanechol 5, 10 and 25 mg, and 100-ct bottles of Oxybutynin. The individual batch numbers and expiration dates, as well as descriptions of each affected pill, are available in the recall press release.

The original recall, issued last week, included Jantoven Warfarin Sodium, USP, 3mg Tablets from lot #284081. That has also been expanded to 15 more lots in strengths from 1 mg to 10 mg.

Jantoven is a form of warfarin, an anticoagulant which has been approved for use in the U.S. since the early 1950s. It is the most commonly used anticoagulant in the United States and is also sold under the brand names Coumadin, Marevan, Lawarin and Waran. It is also sold as a generic.

Consumers and pharmacists with questions can call 1-877-492-4791. Adverse reactions should be reported to the FDA’s Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.