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Recall Observatory FDA recall evidence

Drug 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

D-1543-2014

July 31, 2014

Class II

Product summary

Firm
Ben Venue Laboratories Inc
Event
Event 68800
Status
Terminated
Classification
Class II
Quantity
7172 vials
Official record key
drug-enforcement:D-1543-2014

Official wording

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

Code information: Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility