US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 10, 2021 (6 years ago)

Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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 was recalled

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.

Recalling firm
Teva Pharmaceuticals USA
NDC code
0703-9258-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0273-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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