Drug & medication recalls Moderate risk

Zydus Pharmaceuticals USA Inc recalls Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distr…

Recall date
August 18, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1137-2017
FDA classification
Class II
Brand / firm
Zydus Pharmaceuticals USA Inc
Sold / distributed
Nationwide within United States

Why it was recalled

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

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

What was recalled

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8

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