If you take the anticoagulant drug warfarin, you may want to check with your doctor about a voluntary recall after the drug maker identified one mislabeled bottle.
Upsher-Smith Laboratories of Maple Grove, Minn., issued a voluntary recall on one lot of their drug Jantoven (generic name warfarin) after one mislabeled bottle was identified before its tablets were dispensed. The company issued the recall on February 16, 2011, when a bottle was discovered labeled as 3-mg tablets when it actually contained 10-mg tablets.
The warfarin recall affects one lot (9,415 bottles) of Jantoven Warfarin Sodium, USP, with a September 2012 expiration date (lot # 284081). The bottles were distributed to pharmacies throughout the United States. The mislabeled pills are easily distinguished from one another. Both tablets have the number 832 on one side and the letters WRF with a line on the other side. However, the 3-mg pill is tan with the number 3 below the line. The 10-mg pill is white with the number 10 below the line.
What Is Warfarin?
Warfarin is an anticoagulant usually prescribed to patients who are at risk for blood clots, stroke and heart attack. A patient mistakenly taking the higher dose could experience excessive blood thinning, which could lead to a life-threatening hemorrhage. So far, no adverse events have been reported because of these mislabeled tablets.
If you think your medicine may be affected, contact your pharmacist and doctor. Do not change your dosage or stop taking your medicine. Warfarin has a very narrow effective range in the bloodstream, so most patients have regular blood tests to ensure their dosage is correct. Changing the dosage abruptly can affect these levels. Your doctor can tell you if you need to make any changes, but so far, none of the mislabeled tablets have reached patients.
Other Recalls
Upsher-Smith Laboratories issued a second precautionary recall on several other drugs. No mislabeled drugs have been found among this group, but they were produced on the same line as the mislabeled warfarin. These include voluntary recalls on the prescription drugs Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol and Oxybutynin, in addition to the original recall on Jantoven. The manufacturer is working with pharmacies and wholesalers and the U.S. Food and Drug Administration to arrange for the return of these products.
Consumers and pharmacists with questions can call 1-888-650-3789 for more information and to access product details.
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