Home / Recalls / Ben Venue Laboratories Inc / D-1543-2014

D-1543-2014 Class II Terminated

Recalled by Ben Venue Laboratories Inc — Bedford, OH

Recall Details

Product Type
Drugs
Report Date
August 27, 2014
Initiation Date
July 31, 2014
Termination Date
December 2, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7172 vials

Product Description

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.

Distribution Pattern

Nationwide

Code Information

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

Other recalls by Ben Venue Laboratories Inc

  • D-1326-2014 Class I — Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, (February 14, 2014)
  • D-036-2013 Class II — Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manu (July 5, 2012)
  • D-1697-2012 Class I — Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vi (June 26, 2012)
  • D-1376-2012 Class II — Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL s (May 1, 2012)
  • D-1377-2012 Class II — Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, pa (May 1, 2012)