Epoprostenol Sodium for Injection recalled over sterility concerns
- Recall date
- July 29, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Teva Pharmaceuticals USA recalls Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19…
- Recall number
- D-0738-2021
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Product was distributed Nationwide, including Puerto Rico.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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