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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

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.
Recall Number D-1369-2012
Classification Class II
Code Info Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
Product Distributed Qty 83,701 autoinjectors
Reason For Recall Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.

Event Detail

Event Id 62015
Product Type Drugs
Status Ongoing
Recalling Firm Meridian Medical Technologies a Pfizer Company
City Saint Louis
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide, Italy, Singapore, Sweden, and Canada.