Recalls / Class II
Class IID-1543-2014
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
- Affected lot / code info
- Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
Why it was recalled
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Recalling firm
- Firm
- Ben Venue Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Northfield Rd, Bedford, Ohio 44146-4650
Distribution
- Quantity
- 7172 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-31
- FDA classified
- 2014-08-18
- Posted by FDA
- 2014-08-27
- Terminated
- 2014-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1543-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.