Drug product
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
D-1290-2020
Product summary
- Event
- Event 85770
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,224 bottles
- Official record key
drug-enforcement:D-1290-2020
Official wording
Reason: Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Code information: Lot # Q900683, Exp. 10/31/2022
Distribution pattern: Nationwide within the US.
Derived failure modes
-
Unknown
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.