Ben Venue Recalls Vecuronium Bromide Injection Due to Particulate Matter
Ben Venue Laboratories is recalling Vecuronium Bromide for Injection due to the presence of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Ben Venue Laboratories Inc is recalling 797 boxes of Vecuronium Bromide for Injection, 20 mg per vial (10 x 10 mg vials per carton). The product is identified by NDC 55390-039-10, Lot #2067134, with an expiration date of 5/31/2013.
The recall was initiated because of the presence of particulate matter in the product. The affected units were distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact Ben Venue Laboratories for further instructions.
The recalled product
- Product
- Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
- Manufacturer
- Ben Venue Laboratories Inc
- Category
- Drug — Injectable
- Hazard
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)
- Lot #2067134 Exp 5/31/2013
- NDC 55390-039-10
Distribution
Distributed nationwide across the United States.
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