Class II · Moderate risk Terminated
Quinapril Tablets USP
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Quinapril Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
What was recalled
Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-688-15
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0401-2015
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 Quinapril recalls
See all
Class II · Moderate risk Terminated
Quinapril Tablets USP
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk Completed
Quinapril and Hydrochlorothiazide Tablets
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
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