FDA recall D-1369-2012

Product

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.

Distribution

Nationwide, military, Italy, Singapore, Sweden, and Canada.

Key facts

Status

Terminated

Initiation date

2012-06-06

Report date

2012-06-20

Termination date

2013-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Louis, MO, United States

Primary source

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