Ben Venue Recalls Acetylcysteine Solution Due to Glass Particulate
Ben Venue Laboratories is recalling 5,131 vials of Acetylcysteine Solution, USP, 10% due to the presence of glass particulate matter.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Ben Venue Laboratories, Inc. is recalling 5,131 vials of Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only (NDC 0054-3025-02). The recall was initiated after the firm found a glass particulate in one lot of the product during a review of retain samples.
The affected product is identified by lot number 2005479 and expiration date 03/14. The product was distributed nationwide.
This is a Class I recall. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
- Manufacturer
- Ben Venue Laboratories Inc
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 5,131
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 2005479
- Exp 03/14
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ben Venue Laboratories Inc
See all →- SevereBen Venue Recalls Cytarabine for Injection Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- ModerateBen Venue Recalls Leucovorin Calcium Injection Due to Particulate Matter
FDA (Drugs) · 2012-11-07
- SevereBen Venue Recalls Vecuronium Bromide Injection Due to Particulate Matter
FDA (Drugs) · 2012-10-03
- ModerateBen Venue Recalls Octreotide Acetate Injection Due to Potential Low Fill Volume
FDA (Drugs) · 2012-06-20
- ModerateBen Venue Recalls Midazolam HCl Injection Due to Potential Low Fill Volume
FDA (Drugs) · 2012-06-20
Same hazard · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02