CYTARAbine for Injection USP recall: Sterility Concern
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
Why was CYTARAbine for Injection USP recalled?
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
- 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
- Recalling firm
- Ben Venue Laboratories Inc
- Quantity
- 7172 vials
- Distribution
- Nationwide
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)