Recalls / Class II
Class IID-409-2014
Product
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
- Brand name
- Quinapril
- Generic name
- Quinapril
- Active ingredient
- Quinapril Hydrochloride
- Route
- Oral
- NDCs
- 68180-554, 68180-556, 68180-557, 68180-558, 68180-559
- FDA application
- ANDA077690
- Affected lot / code info
- Lot 3110358 Exp. 12/13
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
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 22, 896 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-09-17
- FDA classified
- 2014-01-10
- Posted by FDA
- 2014-01-22
- Terminated
- 2016-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-409-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.