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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Recall Number D-296-2013
Classification Class II
Code Info Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Product Distributed Qty 12770 bottles
Reason For Recall cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.

Event Detail

Event Id 64869
Product Type Drugs
Status Ongoing
Recalling Firm Jubilant Cadista Pharmaceuticals Inc.
City Salisbury
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-11
Initial Firm Notification of Consignee or Public
Distribution Pattern Nationwide
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