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Recall Observatory FDA recall evidence

Drug 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.

D-1697-2012

June 26, 2012

Class I

Product summary

Firm
Ben Venue Laboratories Inc
Event
Event 62422
Status
Terminated
Classification
Class I
Quantity
797 boxes/10/20 mg vials
Official record key
drug-enforcement:D-1697-2012

Official wording

Reason: Presence of Particulate Matter

Code information: Lot #2067134 Exp 5/31/2013, NDC 55390-039-10

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter