Drug 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
D-1536-2022
Product summary
- Event
- Event 90859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,802 1000-count bottles
- Official record key
drug-enforcement:D-1536-2022
Official wording
Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Code information: Lot # Q201182, exp. date March 2024
Distribution pattern: Product was distributed to major distributors/wholesalers nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance