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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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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.

Product Detail

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