Agency classClass IIOur severity:Severe FDA (Drugs)·D-0274-2021·Announced 2021-03-03

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 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
Hazard: sterility-failure
infection-risk
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 15 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility failure