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Recall Observatory FDA recall evidence

Drug product

Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01

D-0738-2021

July 29, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88442
Status
Terminated
Classification
Class II
Quantity
12,698 vials
Official record key
drug-enforcement:D-0738-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 31329113B, exp. date 05/2022

Distribution pattern: Product was distributed Nationwide, including Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility