Teva Recalls Epoprostenol Sodium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in a sterile injectable product, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, NDC 0703-1985-01. The recall involves 12,629 vials with Lot # 31327537B and an expiration date of 09/2021. The product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. Manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery, which led to a lack of sterility assurance for these sterile injectable products.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Medication
- Affected units
- 12,629
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 # 31327537B
- exp. date 09/2021
Distribution
Part of a larger recall action
This product is one of 15 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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