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

Firm: Ben Venue Laboratories Inc

Classification: Class II

Status: Terminated

Report Date: 20140827

Initiation Date: 20140731

Termination Date: 20141202

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

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