Drug product
Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01
D-1272-2019
Product summary
- Event
- Event 82714
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1272-2019
Official wording
Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Code information: Z804517, Nov 30, 2020
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mix-up