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
Reported: August 25, 2021 Initiated: July 29, 2021 #D-0738-2021
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
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 12,698 vials
- Distribution
- Product was distributed Nationwide, including Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 12,698 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0738-2021.
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