CLASS II Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Sterile Diluent for Epoprostenol Sodium for Injection vial recalled
Teva Pharmaceuticals USA is recalling Sterile Diluent for Epoprostenol Sodium for Injection vial (, distributed nationwide in the US. The recall was initiated on 10 Feb 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0273-2021
- FDA event ID
- 87298
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2021
- FDA classified
- 21 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Feb 2021 | Recall initiated by company | |
| 21 Feb 2021 | Classified by FDA | +11 days |
| 3 Mar 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Product was distributed nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # 31326845B, exp. date 03/2021 Lot # 31327844B, exp. date 09/2021
Where was it sold?
Product was distributed nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 87298This product is part of a recall event; the main page for the event is Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng) vial recalled.
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