Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to breakage and glass flying when pressurized during administration. Affected lots expire Dec 2023 to Mar 2024.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Exela Pharma Sciences is recalling 50mL single-dose sodium bicarbonate injection vials because they can shatter and send glass flying when pressurized during medical use. This poses a serious risk of injury to healthcare workers handling the vials.
The vials can break and send glass flying when pressurized during preparation for medical administration. This creates a risk of serious injury from sharp glass fragments to healthcare workers handling the vials.
Healthcare professionals using the vials for medical administration are most at risk. Patients receiving the injection would not be directly affected as the vial is used by medical staff.
Check for vials labeled 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) in cartons of 20. The vials have NDC numbers 72572-740-1 and cartons NDC 72572-740-20. Lots P0001497 (expiring Dec 2023), P0001600 (expiring Feb 2024), or P0001663 (expiring Mar 2024).
Immediately stop using the recalled vials as they can shatter during medical preparation, causing serious injury.
The vials can break and send glass flying when pressurized during preparation for medical administration, posing a serious injury risk to healthcare workers.
Lots P0001497 (expiring Dec 2023), P0001600 (expiring Feb 2024), and P0001663 (expiring Mar 2024).
Look for vials labeled 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) in cartons of 20 with NDC 72572-740-20 and vials NDC 72572-740-1.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0023-2023 — Exela Exela Hello, I own a Exela that is covered by recall D-0023-2023 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.
