Home / Recalls / Ben Venue Laboratories Inc / D-1326-2014

D-1326-2014 Class I Terminated

Recalled by Ben Venue Laboratories Inc — Bedford, OH

Recall Details

Product Type
Drugs
Report Date
May 28, 2014
Initiation Date
February 14, 2014
Termination Date
June 29, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,131 vials

Product Description

Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02

Reason for Recall

Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution

Distribution Pattern

Nationwide.

Code Information

2005479, Exp 03/14

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-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)