D-0738-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,698 vials
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed Nationwide, including Puerto Rico.
Code Information
Lot #: 31329113B, exp. date 05/2022