Epoprostenol Sodium for Injection recall: Sterility Concern
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
Why was Epoprostenol Sodium for Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 31329113B, exp. date 05/2022
- Product
- 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
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 12,698 vials
- Distribution
- Product was distributed Nationwide, including Puerto Rico.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)