Recall D-1242-2019

Product type

Drugs

Firm

Zydus Pharmaceuticals USA Inc

Status

Ongoing

Classification

Class III

Product

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05

Reason

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

Distribution

Nationwide in the USA

Report date

2019-05-01