Diazepam Injection
FDA Recall NDC 11704-600
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diazepam (NDC 11704-600). A significant event, classified as Class II, was initiated on Jun 06, 2012 by Meridian Medical Technologies Llc. The reported reason for this action was: "Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Jun 06, 2012
Jun 20, 2012
83,400 autoinjectors
Recall Profile & Regulatory Data
Event ID
62015
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Meridian Medical Technologies a Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Termination Date
Aug 05, 2013
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.
Batch or Lot Expiration Information
Lot# : 8D1082, Exp 01/13; 8D1151, Exp 03/13
Affected Packages Involved in this Recall
11704-600-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
