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

FDA recall notice · announced August 27, 2014 · Ben Venue Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Notes

Distribution: Nationwide
Lot/code information: Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
Quantity: 7172 vials
Status: Terminated
Products in this recall event:
- 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 5 (D-1543-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.