Zydus Pharmaceuticals USA Inc recalls ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-…

Recall date

March 6, 2017

Source

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

Recall number

D-0605-2017

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.