Home / Recalls / Ben Venue Laboratories Inc / D-1376-2012

D-1376-2012 Class II Terminated

Recalled by Ben Venue Laboratories Inc — Bedford, OH

Recall Details

Product Type
Drugs
Report Date
June 20, 2012
Initiation Date
May 1, 2012
Termination Date
August 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,161 packs

Product Description

Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.

Reason for Recall

Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot #1856177, Exp 06/30/13

Other recalls by Ben Venue Laboratories Inc

  • D-1543-2014 Class II — CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only (July 31, 2014)
  • 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-1377-2012 Class II — Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, pa (May 1, 2012)