The Recall Desk
SevereFDA (Drugs)·D-1697-2012·Announced 2012-10-03

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

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.