Exela Pharma Sciences recalls 8.4% Sodium Bicarbonate Injection vials due to potential silicone particulate matter. This could cause serious injury if injected. Affected vials have specific NDC codes and expiration dates.
Presence of Particulate Matter: Silicone
Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection vials that may contain silicone particles. If injected, these particles could cause serious injury. The recall affects specific vial sizes and expiration dates.
Silicone particles in the injection could cause blockages or irritation when injected into the bloodstream. This poses a serious risk of injury if the product is used without proper filtration.
Healthcare professionals and patients who have been prescribed this injection. Those using the recalled vials for intravenous administration are most at risk.
Check for vials labeled '8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL)' with specific NDC codes: 51754-5001-1 (20x50 mL) or 72572-740-01 (20x50 mL). The vials have expiration dates listed in the product description.
Verify the expiration date on the vial label to ensure it matches the dates listed in the recall notice.
If you have the recalled vial, contact your healthcare provider for guidance on whether to use it or return it.
The recall is due to the presence of silicone particles in the injection, which could cause serious injury if injected.
Vials with NDC codes 51754-5001-1 (20x50 mL) or 72572-740-01 (20x50 mL) that have specific expiration dates listed in the recall notice.
No, but you should check the expiration date and contact your healthcare provider for guidance before using.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0116-2024 — Exela Exela Hello, I own a Exela that is covered by recall D-0116-2024 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.
