FDA-Drug2012-06-20Class II

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.

Meridian Medical Technologies a Pfizer Company
Hazard

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

Sold states
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Affected count
83,400 autoinjectors
Manufactured in
1945 Craig Rd, Saint Louis, MO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1369-2012

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