Teva Recalls Sterile Diluent for Epoprostenol Sodium Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Sterile Diluent for 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 sterile injectable product with a lack of sterility assurance, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 26,373 vials of Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09). The affected lots are # 31326845B (exp. 03/2021) and # 31327844B (exp. 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 lots and contact Teva Pharmaceuticals or their local FDA office for further instructions. This is a prescription-only product.
The recalled product
- Product
- Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Diluent
- Affected units
- 26,373
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 (3)
- Lot # 31326845B
- exp. date 03/2021 Lot # 31327844B
- 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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