Drug product
Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
D-1847-2019
Product summary
- Event
- Event 83672
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60 cartons
- Official record key
drug-enforcement:D-1847-2019
Official wording
Reason: Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Code information: Lots 186509 and 186982, exp 6/30/2021
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing