FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15...

  • U.S. Food and Drug Administration
  • June 20, 2012
  • ID: D-1369-2012

Drug Enforcement Report Details

Recall NumberD-1369-2012
Recalling FirmMeridian Medical Technologies a Pfizer Company
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternNationwide, military, Italy, Singapore, Sweden, and Canada.
StatusTerminated
Product Description

Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01.

Reason for Recall

Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.

Code Information

Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.