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
Reported: August 27, 2014 Initiated: July 31, 2014 #D-1543-2014
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.
Details
- Recalling Firm
- Ben Venue Laboratories Inc
- Units Affected
- 7172 vials
- Distribution
- Nationwide
- Location
- Bedford, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ben Venue Laboratories Inc. Units affected: 7172 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2014. Severity: Moderate. Recall number: D-1543-2014.
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