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FDAFebruary 10, 2021drug

Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

teva pharmaceuticalsteva

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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