Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class II recall. The hazard—lack of assurance of sterility in an injectable pharmaceutical product—poses a significant risk of serious adverse health outcomes if administered, particularly given that epoprostenol is used to treat serious pulmonary conditions. Although no reported illnesses or hospitalizations are stated in the source, the potential harm from non-sterile injectable medication meets the Severe criteria for Class II recalls.
Plain-English summary
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials (NDC 0703-1995-01) due to lack of assurance of sterility.
The recalled lot is #31329113B with an expiration date of 05/2022. Approximately 12,698 vials were distributed nationwide, including Puerto Rico.
Epoprostenol Sodium for Injection is a prescription medication. Patients currently using this product should consult their healthcare provider or pharmacist before discontinuing use and to discuss alternative treatment options. Healthcare providers should also review their records to identify potentially affected patients.
The recalled product
- 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
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Pharmaceutical
- Affected units
- 12,698
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 31329113B
- exp. date 05/2022
Distribution
Part of a larger recall action
This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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