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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64604
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 2013-03-05
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01. Lot #: MM8490, Exp 09/14 Class II Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. 13,320 bottles D-202-2013