Recalls / Class II
Class IID-1079-2020
Product
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
- 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 #: Q900580, Exp 9/2021
Why it was recalled
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
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
- 25,944 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-04-01
- FDA classified
- 2020-04-02
- Posted by FDA
- 2020-04-08
- Terminated
- 2021-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1079-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.