Drug 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
D-1543-2014
Product summary
- Event
- Event 68800
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7172 vials
- Official record key
drug-enforcement:D-1543-2014
Official wording
Reason: Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Code information: Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility