Recalls / Class II
Class IID-1536-2022
Product
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
- 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 # Q201182, exp. date March 2024
Why it was recalled
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
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
- 11,802 1000-count bottles
- Distribution pattern
- Product was distributed to major distributors/wholesalers nationwide.
Timeline
- Recall initiated
- 2022-09-13
- FDA classified
- 2022-09-15
- Posted by FDA
- 2022-09-21
- Terminated
- 2024-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1536-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.