Reported May 28, 2014 · Terminated

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

Ben Venue Laboratories Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ben Venue Laboratories Inc · 300 Northfield Rd · Bedford, OH · 44146

Is this the product you have?

  • Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Lot codes and dates
    • 2005479
    • Exp 03/14
Amount recalled
5,131 vials

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 29, 2015 · Data as of Sep 19, 5:03 PM UTC

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