FDA-Drug2014-08-27Class II
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
Ben Venue Laboratories Inc
Hazard
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Sold states
Nationwide
Affected count
7172 vials
Manufactured in
300 Northfield Rd, Bedford, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2014Don't want to check this manually?
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