Recall: D-1369-2012

Class II - Potentially Harmful

Class IIClassification

2012-06-06Initiated

TerminatedStatus

Meridian Medical Technologies Firm

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

Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.

Distribution

Nationwide, military, Italy, Singapore, Sweden, and Canada.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.