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U.S. Department of Health and Human Services

Enforcement Report - Week of March 2, 2016

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Product Detail

Product Description risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Recall Number D-0725-2016
Classification Class III
Code Info Lot #: MP4967, Expiry: 04/2016.
Product Distributed Qty 9504 Bottles
Reason For Recall Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

Event Detail

Event Id 73221
Product Type Drugs
Status Ongoing
Recalling Firm Zydus Pharmaceuticals USA Inc
City Pennington
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2016-01-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide including Puerto Rico