Drug & medication recalls Moderate risk

Zydus Pharmaceuticals USA Inc recalls Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC…

Recall date
November 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0101-2018
FDA classification
Class II
Brand / firm
Zydus Pharmaceuticals USA Inc
Sold / distributed
Nationwide

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, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534

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