FDA-Drug2014-01-22Class II

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

Lupin Pharmaceuticals Inc.
Hazard

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Sold states
Nationwide and Puerto Rico
Affected count
22, 896 bottles
Manufactured in
111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-409-2014

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