Safety Alerts & Recalls

What does this mean?

No serious injuries have been reported in connection from this recall. That said, this recall alert is a good reminder for you to check your prescription before leaving the pharmacy and to talk to your pharmacist if a refill of warfarin, Coumadin, or Jantoven tablets does not look the same as what you usually receive.

If you are currently taking Jantoven Warfarin Sodium USP Tablets 3mg, you should also check your current prescription as soon as possible and confirm that your bottle contains the correct tablets. The two Jantoven tablets can be identified by color and markings on the tablet. The 3mg tablet is tan and is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is white and is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832. To view photos of the two strengths of tablets, please visit: http://www.fda.gov/Safety/Recalls/ucm243818.htm

If you take Jantoven Warfarin Sodium, USP Tablets 3mg, and think there are problems with your prescription, please follow up with your pharmacist . If you are experiencing excessive bleeding or bruising please seek medical attention right away. If you have any other questions about your medicine, please follow up with your doctor, pharmacist, or other healthcare professional.

Consumers and pharmacists can call the Upsher-Smith 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). Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of the recalled medicine to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Upsher-Smith Announces Nationwide Recall Of Jantoven Warfarin Sodium Tablets, 3mg, Due To Mislabeled Bottles

Upsher-Smith Laboratories, Inc. is voluntarily recalling one lot (lot #284081) of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, or "blood thinning" medicine that prevents the formation of blood clots. The company is initiating the recall because a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg 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 10mg warfarin for 3mg warfarin is that overdosing can lead to excessive anticoagulation which may result in life threatening bleeding.

Warfarin is sold in different strength tablets (1 mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 7.5mg, and 10mg) and is available as the generic name warfarin and brand names Coumadin and Jantoven. This recall only involves a single lot of Jantoven Warfarin Sodium, USP, 3mg Tablets. No other brands or strengths of warfarin are involved in the recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-02-18
Last Updated: 2011-02-18

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