Drug product
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
D-1140-2015
Product summary
- Event
- Event 71219
- Status
- Terminated
- Classification
- Class II
- Quantity
- 925 cartons (30 tablets in each carton)
- Official record key
drug-enforcement:D-1140-2015
Official wording
Reason: Failed dissolution specifications
Code information: Lot #140849
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications