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 II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
What was recalled
Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-556-09
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-408-2014
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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