Drug product

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

D-1273-2019

April 25, 2019

Class II

Product summary

Firm: Zydus Pharmaceuticals USA Inc
Event: Event 82714
Status: Terminated
Classification: Class II
Quantity: 3900
Official record key: drug-enforcement:D-1273-2019

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, exp Nov 30, 2020

Distribution pattern: Nationwide

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Labeling; Label Mix-up