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U.S. Department of Health and Human Services

Enforcement Report - Week of July 2, 2014

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Product Detail

Product Description Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
Recall Number D-1407-2014
Classification Class II
Code Info JKM7188A
Product Distributed Qty 200 vials
Reason For Recall Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.

Event Detail

Event Id 68209
Product Type Drugs
Status Ongoing
Recalling Firm Caraco Pharmaceutical Laboratories, Ltd.
City Detroit
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-09
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern OH