Epoprostenol Sodium for Injection — Class II drug recall D-0280-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2021-03-03, distributed nationwide. Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for m
| Recall number | D-0280-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-02-10 |
| Classified | 2021-02-21 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 12,609 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 00703-1995-01 |
| Lot numbers | 31326456B |
| Expiration dates | 2021-02-28 |
Product
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0280-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.