Status
Terminated
Drug Enforcement D-1369-2012
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Classification
Class II
Report Date
June 20, 2012
Termination Date
August 5, 2013
Product Information
- 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.
- Product quantity
- 83,400 autoinjectors
- Reason for recall
- Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide, military, Italy, Singapore, Sweden, and Canada.
Location & Firm
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
- Address
-
1945 Craig Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1369-2012
- Event ID
- 62015
- Recall initiation date
- June 6, 2012
- Center classification date
- June 11, 2012
- Code info
- Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
- More code info
- —