FDA recall D-1543-2014

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-31

Report date

2014-08-27

Termination date

2014-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2014