FDAFDA · Food and drugs·Recall number D-1543-2014
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
Published August 27, 2014 · Recall initiated: July 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ben Venue Laboratories Inc
- Distributor
- Nationwide
- Lot
- Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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