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Recall Observatory FDA recall evidence

Drug product

Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

D-0279-2021

February 10, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 87298
Status
Terminated
Classification
Class II
Quantity
33,6697 vials
Official record key
drug-enforcement:D-0279-2021

Official wording

Reason: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Code information: Lot # 31325712B, exp. date 12/2021 31326320B, exp. date 02/2022 31326457B, exp. date 02/2022 31327880B, exp. date 10/2022

Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility