Recalls / Class II
Class IID-1077-2018
Product
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, 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 #: H800414, Exp. 12/2019
Why it was recalled
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 11,706 bottles
- Distribution pattern
- Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
Timeline
- Recall initiated
- 2018-08-13
- FDA classified
- 2018-08-13
- Posted by FDA
- 2018-08-22
- Terminated
- 2019-10-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1077-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.