Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Quinapril Tablets USP, 10 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 68180-557-09
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.
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.