Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
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: Contains N-nitrosoquinapril above the acceptable limits.
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
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