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.
Reported: March 3, 2021 Initiated: February 10, 2021 #D-0280-2021
Product Description
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 12,609 vials
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 12,609 vials.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on March 3, 2021. Severity: Moderate. Recall number: D-0280-2021.
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