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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 due to microbial recovery exceeding acceptance levels, which poses a significant risk of serious injury.
Plain-English summary
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, NDC 0703-1995-01. The recall involves 12,609 vials from Lot # 31326456B with an expiration date of 02/28/2021.
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.
The product was distributed nationwide in the USA and Puerto Rico. Patients and healthcare providers should stop using the affected vials and contact their healthcare provider or Teva Pharmaceuticals for further instructions.
The recalled product
- Product
- Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 12,609
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 # 31326456B
- exp. date 02/28/2021
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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