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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
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