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U.S. Department of Health and Human Services

Enforcement Report - Week of August 27, 2014

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Product Detail

Product Description CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
Recall Number D-1543-2014
Classification Class II
Code Info Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
Product Distributed Qty 7172 vials
Reason For Recall Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Event Detail

Event Id 68800
Product Type Drugs
Status Ongoing
Recalling Firm Ben Venue Laboratories Inc
City Bedford
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-07-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide