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
- Recalling Firm
- Meridian Medical Technologies a Pfizer Company
- 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.
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