Zydus Pharmaceuticals USA Inc recalls Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distribut…

Recall date

April 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1242-2019

FDA classification

Class III

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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