PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 28, 2014 Initiated: February 14, 2014 #D-1326-2014

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

Details

Units Affected
5,131 vials
Distribution
Nationwide.
Location
Bedford, OH

Frequently Asked Questions

What product was recalled?
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02. Recalled by Ben Venue Laboratories Inc. Units affected: 5,131 vials.
Why was this product recalled?
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2014. Severity: Critical. Recall number: D-1326-2014.