Drug recall D-1369-2012
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.
Reason for recall
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Lots and codes
Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
Recall details
- Recalling firm
- Meridian Medical Technologies a Pfizer Company, Saint Louis, MO
- Quantity
- 83,400 autoinjectors
- Distribution
- Nationwide, military, Italy, Singapore, Sweden, and Canada.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 6, 2012
- Terminated
- August 5, 2013
Related products
- Diazepam – drug information
- NDC 11704-600 Diazepam · Diazepam 10 mg/2mL · Meridian Medical Technologies LLC