Class II · Moderate risk Terminated
Diazepam Oral Solution
Reason Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0078-2015
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 Injection
Reason Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
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