Drug product
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
D-1077-2018
Product summary
- Event
- Event 80789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,706 bottles
- Official record key
drug-enforcement:D-1077-2018
Official wording
Reason: Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Code information: Lot #: H800414, Exp. 12/2019
Distribution pattern: Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance