RecallDepth
Class II Terminated

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

Company
Ben Venue Laboratories Inc
Recall Initiated
July 31, 2014
Posted
August 27, 2014
Recall Number
D-1543-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
7172 vials
Firm Location
Bedford, OH, United States

Reason for Recall

Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Distribution

Nationwide

Lot / Code Info

Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14

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