FDA Drug Class II — Moderate

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.

Hazard

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

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Products

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 subs
Brand
Meridian Medical Technologies a Pfizer Company
UPC
Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13

Units Affected

83,400 autoinjectors

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