FDAFDA · Food and drugs·Recall number D-0738-2021
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
Published August 25, 2021 · Recall initiated: July 29, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed Nationwide, including Puerto Rico.
- Lot
- Lot #: 31329113B, exp. date 05/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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