Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

Bristol-Myers Squibb Recalls Coumadin 5 mg Tablets
Bristol-Myers Squibb Co. is recalling one lot of its blood thinner Coumadin after finding an oversize tablet in a returned bottle. The tablet was found to contain more of the active ingredient than expected. The recall affects lot number 9H49374A of Coumadin 5mg tablets with an expiration date of Sept. 30, 2012. Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding. Coumadin contains the active ingredient warfarin and comes in many different strengths of tablets. Warfarin is available as a generic product made by other manufacturers and is also available under the name Jantoven. Only Coumadin 5 mg tablets manufactured by Bristol-Myers Squibb from lot number 9H49374A have been recalled. No other Coumadin or warfarin products from other manufacturers are involved in this recall. Bristol-Myers Squibb is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and will issue recall communications to all physicians and other customers involved. For more information, please visit: http://www.bms.com/news/features/2011/Pages/coumadinrecall_2011.aspx
Learn More

Bristol-Myers Squibb Expands May 2011 Recall: More Tablet Strengths Recalled
Bristol-Myers Squibb Company is expanding its May 2, 2011 voluntary recall of one lot of Coumadin Tablets, 5 mg, to include an additional 17 lots of Coumadin in the U.S. which include 2.5 mg, 4 mg, 7.5 mg and 10 mg tablets. The previous recall issued May 2, 2011 was based on the company’s testing of tablets from a Coumadin 5 mg bottle in which a single tablet was found to be higher in potency than expected. The company has determined that the same source of active ingredient used in the previously recalled Coumadin 5 mg tablet lot was used in the additional lots being recalled. To date, testing by Bristol-Meyers Squibb has not identified any specific problems with the additional lots being recalled. However, the company is conducting the recall as a precautionary measure. Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots, which could lead to heart attack or stroke; whereas an increase of active ingredient may increase the risk of bleeding. Given the current findings from this recall, the probability of either scenario occurring appears to be very low. Coumadin contains the active ingredient warfarin and comes in many different strengths of tablets. Warfarin is available as a generic product made by other manufacturers and is also available under the name Jantoven. No other warfarin products from other manufacturers are involved in this recall. For more information and to view a list of recalled lot numbers, please visit: http://www.bms.com/news/features/2011/Pages/ExpandsVoluntaryRecallofCOUMADIN.aspx
Learn More

Date Published Title Drug Source
2011-05-02 Bristol-Myers Squibb Recalls Coumadin 5 mg Tablets Warfarin Manufacturer
2011-06-15 Bristol-Myers Squibb Expands May 2011 Recall: More Tablet Strengths Recalled Warfarin Manufacturer
2013-06-13 Zydus Pharmaceuticals Recalls One Lot of Warfarin 2 mg Tablets Warfarin FDA
2014-05-08 Alere Recalls Alere INRatio®2 PT/INR Professional Test Strips Warfarin FDA
2010-03-11 Black Box Warning for WinRho SDF Warns About Potentially Life Threatening Reaction WinRho SDF Manufacturer
2010-10-15 FDA Provides Answers to Common Questions About Unapproved Chelation Products FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Yohimbine Manufacturer
2009-01-14 Update on FDA Safety Review Zafirlukast FDA
2009-06-12 Updated Safety Information from FDA Safety Review Zafirlukast FDA
2009-08-28 Updated Prescribing Information Available Zafirlukast FDA
2009-11-04 FDA Answers Common Questions About Relenza Zanamivir FDA
2009-05-28 Recall on Single Lot of Zicam Multisymptom Cold & Flu Nighttime Formula Zicam FDA
2009-06-16 Warnings on Three Zicam Intranasal Zinc Products Zicam FDA
2009-05-28 Recall on Single Lot of Zicam Multisymptom Cold & Flu Nighttime Formula Zicam Cold and Flu FDA
2012-12-19 Zicam Extreme Congestion Relief Nasal Gel Recalled Because of Bacteria Contamination Manufacturer
2008-09-18 FDA Stops Imports of Ranbaxy Products Zidovudine FDA
2009-01-14 Update on FDA Safety Review Zileuton FDA
2009-06-12 Updated Safety Information from FDA Safety Review Zileuton FDA
2009-08-28 Updated Prescribing Information Available Zileuton FDA
2009-06-16 Warnings on Three Zicam Intranasal Zinc Products Zinc FDA
Back to Consumer Med Safety