Recalls / Class II
Class IID-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.
- Brand name
- Diazepam
- Generic name
- Diazepam
- Active ingredient
- Diazepam
- Route
- Intramuscular
- NDC
- 11704-600
- FDA application
- NDA020124
- Affected lot / code info
- Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
Why it was recalled
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Recalling firm
- Firm
- Meridian Medical Technologies a Pfizer Company
- Manufacturer
- Meridian Medical Technologies LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1945 Craig Rd, Saint Louis, Missouri 63146-4105
Distribution
- Quantity
- 83,400 autoinjectors
- Distribution pattern
- Nationwide, military, Italy, Singapore, Sweden, and Canada.
Timeline
- Recall initiated
- 2012-06-06
- FDA classified
- 2012-06-11
- Posted by FDA
- 2012-06-20
- Terminated
- 2013-08-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1369-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.