Recalls / Class III
Class IIID-0650-2017
Product
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
- 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
- Batch number G303703, exp 3/2016
Why it was recalled
Failed Impurities/Degradation Specifications; Impurity A
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 15,168 bottes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-12-07
- FDA classified
- 2017-04-06
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0650-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.