Teva Pharmaceuticals recalls Epoprostenol Sodium injection vials due to lack of sterility assurance. This drug, used for severe heart conditions, may cause infections if not properly sterile.
Lack of Assurance of Sterility
Teva Pharmaceuticals is recalling Epop: 1.5 mg/vial, 10 mL injection vials for potential lack of sterility. This could lead to infections if the medication is not sterile, which is critical for patients with heart conditions.
The medication may not be sterile, which can cause infections in patients who require precise medical treatments. This is especially concerning for individuals with heart conditions who rely on the drug.
Patients prescribed this medication for heart conditions are affected. Those using the product without proper sterility checks are at higher risk.
Check for vials labeled 'Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL' with NDC 0703-1995-01 and lot number 31329113B, expiring May 2022.
Look for the NDC code 0703-1995-01 and lot number 31329113B on the vial label.
The recall is due to potential lack of sterility, which could cause infections. Do not use the product until confirmed safe.
Check the vial label for NDC 0703-1995-01 and lot number 31329113B, expiring May 2022.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0738-2021 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0738-2021 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
