Reported Aug 27, 2014 · Terminated
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories,…
Ben Venue Laboratories Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ben Venue Laboratories Inc · 300 Northfield Rd · Bedford, OH · 44146-4650
Is this the product you have?
- 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
- Lot codes and dates
Lot # 0161-13-2167551Exp. 07/14 Lot # 0161-13-2176919Exp. 08/14
- Amount recalled
- 7172 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
This product could cause temporary or reversible health problems — stop using it.
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