Recalls / Class III
Class IIID-1503-2016
Product
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
- Brand name
- Lisinopril
- Generic name
- Lisinopril
- Active ingredient
- Lisinopril
- Route
- Oral
- NDCs
- 68180-512, 68180-513, 68180-517, 68180-980, 68180-981, 68180-982, 68180-979, 68180-514, 68180-515, 68180-516
- FDA application
- ANDA077321
- Affected lot / code info
- Batch number: H303449, Exp 09/16
Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 5,880 bottles
- Distribution pattern
- All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
Timeline
- Recall initiated
- 2016-04-06
- FDA classified
- 2016-09-16
- Posted by FDA
- 2016-09-28
- Terminated
- 2017-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1503-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.