The FDA has announced that certain Warfarin Sodium Tablets (Jantoven), 3mg, are being recalled because of dangerous mislabeling.
The manufacturer, Upsher-Smith Laboratories,has recalled one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets. The recalled lot is numbered as #284081, with an expiration date of September 2012.
If you have questions about how to identify the recalled tablets, there is a way to tell the difference between the 3mg and 10 mg tablets. Feel free to shoot us an email if you want to know how. Or better yet, here are some photos:
The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. 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.