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. |
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