In July, Bristol-Myers Squibb announced the recall of some of their 5 mg single-use Coumadin injections. Six lots are affected in the recall: 00201125, 00201126, 00201127, 00201128, 00201129, and 00201130. The voluntary nationwide recall is a result of visible particulate matter found in some unreleased samples. These lots were distributed in six-count cartons to pharmacies from November 2011 through January 2014. The expiration dates stagger from September 2014 until September 2015.
If your pharmacy has any injections from these lots, do not use or distribute them. Instead, call GENCO, at 855-838-5784, to arrange for the injections to be returned. GENCO can be reached between the hours of 7:00am and 5:00pm Central time.
According to Squibb, Coumadin injections were discontinued in April 2014, as the injectable version of this medication accounted for approximately 0.2% of the total Coumadin use in the United States. Since it is administered only in hospital settings, to patients who are otherwise not able to take Coumadin orally, this only affects hospital pharmacies.
The recalled medication does not present much, if any safety hazard to patients, as the injectable medication is to be inspected prior to administration. Injected material, however, can cause serious adverse reactions, such as embolism. It is also possible patients could suffer allergic reactions to the foreign material. To date, Squibb has not received any product complaints or adverse reports related to this recall.
Coumadin is a blood thinner used to help prevent blood clot formation. It is typically prescribed to prevent heart attack and stroke. This recall does not affect Coumadin oral tablets.
Pharmacists and other hospital staff may contact the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056, if there are any questions or concerns about the medication and/or the recall.
If you should need to report quality problems or adverse reactions associated with the use of this medicine, use the FDA MedWatch Adverse Reporting Program, either online, by fax, or through the mail.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax. Forms can be faxed to 1-800-FDA-0178.