D-1369-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2012
- Initiation Date
- June 6, 2012
- Termination Date
- August 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83,400 autoinjectors
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.
Distribution Pattern
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Code Information
Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13