Drug product
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.
D-1369-2012
Product summary
- Event
- Event 62015
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83,400 autoinjectors
- Official record key
drug-enforcement:D-1369-2012
Official wording
Reason: 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
Distribution pattern: Nationwide, military, Italy, Singapore, Sweden, and Canada.
Derived failure modes
-
Potency or specification failure
Out of Specification