Class II
Terminated
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 10, 2021
- Posted
- March 3, 2021
- Recall Number
- D-0280-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,609 vials
- Firm Location
- Parsippany, NJ, United States
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.
Distribution
Product was distributed nationwide in the USA and Puerto Rico.
Lot / Code Info
Lot # 31326456B, exp. date 02/28/2021
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