Recalls / Class II
Class IID-1290-2020
Product
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
- 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
- Lot # Q900683, Exp. 10/31/2022
Why it was recalled
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 4,224 bottles
- Distribution pattern
- Nationwide within the US.
Timeline
- Recall initiated
- 2020-05-28
- FDA classified
- 2020-06-08
- Posted by FDA
- 2020-06-17
- Terminated
- 2021-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1290-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.