Drug product
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
D-1538-2022
Product summary
- Event
- Event 90873
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,699 blister cards/30 tablets each
- Official record key
drug-enforcement:D-1538-2022
Official wording
Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Code information: Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
Distribution pattern: Distributed to two direct accounts in PA and AK.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance