PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: June 20, 2012 Initiated: June 6, 2012 #D-1369-2012

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.

Reason for Recall

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

Details

Units Affected
83,400 autoinjectors
Distribution
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Location
Saint Louis, MO

Frequently Asked Questions

What product was recalled?
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.. Recalled by Meridian Medical Technologies a Pfizer Company. Units affected: 83,400 autoinjectors.
Why was this product recalled?
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 20, 2012. Severity: Moderate. Recall number: D-1369-2012.