Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05),...
FDA Recall #D-0101-2018 — Class II — November 20, 2017
Product Description
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
Reason for Recall
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Recalling Firm
Zydus Pharmaceuticals USA Inc — Pennington, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
19812 bottles
Distribution
Nationwide
Code Information
a) Z701308, b) Z701309, c) Z701310 exp April 2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated