FDA Safety Alerts Regarding Two Drugs Voluntarily Recalled by Manufacturers

November 12, 2010 4:33 PM

Certain lots of two drugs, Heparin Sodium USP Active Pharmaceutical Ingredient (API) and Methotrexate Injection (50 mg/2 mL and 250 mg/10 mL) vials, have been voluntarily recalled by the manufacturers. Working with Food and Drug Administration (FDA), B. Braun Medical Inc has notified health care providers of a nationwide recall of certain lots of Heparin Sodium USP (API) because testing indicated a trace amount of oversulfated chondroitin sulfate contaminant. The seven affected lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010. The lot numbers are listed in an October 27, 2010 press release available on the FDA Web site. Customers who have product from the recalled product lots should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician.

On October 29, 2010, Sandoz and FDA notified health care professionals of a recall of Methotrexate Injection (50 mg/2 mL and 250 mg/10 mL) vials, due to small glass flakes detected in a limited number of vials in four lots. FDA advises that parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Affected lot numbers and expiration dates are listed in the press release available on the FDA Web site. FDA advises that customers and patients immediately discontinue use of this product. Further, patients are advised to contact their health care provider if they experience any problem that might be related to the use of this product.