Recalls / Class II
Class IID-1250-2020
Product
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
- Affected lot / code info
- Lot # Q000255, Exp 01/2022
Why it was recalled
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Recalling firm
- Firm
- 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
- 11,808 bottles
- Distribution pattern
- Product was distributed Nationwide in the United States.
Timeline
- Recall initiated
- 2020-04-20
- FDA classified
- 2020-04-21
- Posted by FDA
- 2020-04-29
- Terminated
- 2021-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1250-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.