Class II · Moderate risk Terminated
Diazepam Oral Solution
Reason Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Diazepam Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
What 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.
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
- NDC code
- 11704-600-01
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1369-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Diazepam recalls
See all
Class II · Moderate risk Terminated
diazePAM 5 MG/ML INJECTION SOLUTION
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Diazepam Rectal Gel
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class II · Moderate risk Terminated
Diazepam Injection USP 10mg/2mL
Reason Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class II · Moderate risk Terminated
Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
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