Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to breakage and glass flying when pressurized during administration. Affected vials were packaged in cartons of 20 with specific lot numbers.
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 break and send glass flying when pressurized during medical use. This hazard could cause serious injury to healthcare workers handling the vials.
The vials can break and send glass flying when pressurized during preparation for administration. This happens because the vials are made of glass that may not withstand the pressure changes during medical use. The risk is specific to the handling process and not present during normal storage.
Healthcare professionals using the vials for medical administration are most at risk. Patients receiving the injection would not be directly affected since the vials are used by medical staff.
Check for vials labeled '8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose' in cartons of 20. Lot number P0001490 with expiration date 12/2023.
Inspect vials for signs of breakage or cracks before use.
Reach out to Exela Pharma Sciences for specific guidance on handling the vials.
The product is not safe for medical use as it can break and send glass flying during administration. Healthcare professionals should not use these vials.
Look for vials labeled '8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose' in cartons of 20 with lot number P0001490 and expiration date 12/2023.
The recall does not specify a return or disposal process. Contact Exela Pharma Sciences directly for guidance.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0080-2023 — Exela Exela Hello, I own a Exela that is covered by recall D-0080-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
