D-1543-2014 Class II Terminated
FDA drug recall D-1543-2014 was initiated by Ben Venue Laboratories Inc on July 31, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. The recall status is terminated (terminated December 2, 2014). Affected quantity: 7172 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 27, 2014
- Initiation Date
- July 31, 2014
- Termination Date
- December 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7172 vials
Product Description
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 Pattern
Nationwide
Code Information
Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14