Exela Pharma Sciences recalls 25 x 50 mL vials of 8.4% Sodium Bicarbonate Injection due to lack of sterility assurance. This injectable medication is for IV use only and requires immediate action to prevent infection risks.
Lack of Assurance of Sterility
Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection vials because they may not be sterile. Using these vials could lead to infections, especially since the product is for intravenous use only.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. This poses a risk of infection when injected into the bloodstream, which is particularly dangerous for intravenous medications.
Patients prescribed this medication by a healthcare provider. Those using the product without medical supervision are at risk of infection.
Check for vials labeled '8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton'. The NDC numbers 51754-5001-1 (vial) and 51754-5001-4 (carton) with lots 10006417 and 10006418, expiring November 30, 2026.
Discard the vials if you have them, as they may not be sterile and could cause infection.
No, the product lacks assurance of sterility, which means it could contain harmful contaminants and cause infection if used intravenously.
Look for vials with NDC numbers 51754-5001-1 and 51754-5001-4, lots 10006417 or 10006418, expiring November 30, 2026.
Discard the vials immediately to prevent potential infection from using non-sterile medication.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0303-2025 — Exela Exela Hello, I own a Exela that is covered by recall D-0303-2025 from Exela. 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.
