Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to reported breakage and glass flying when pressurized during administration preparation. Affected vials have specific lot numbers and expiration dates.
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 complaints show they can break and send glass flying when pressurized during preparation. This poses a risk of injury to healthcare workers handling the vials.
The vials can break and release glass particles when pressurized during preparation for injection. This creates a risk of cuts or lacerations to healthcare workers handling the vials. The hazard occurs during the preparation process, not during actual administration.
Healthcare professionals using the product for medical administration are most at risk. Patients receiving the injection are not directly affected by the vial breakage hazard.
Check for vials with the brand name 'Exela' and lot numbers listed in the recall notice: P0001370-P0001594, P0001610, P0001618-P0001619, P0001654, P0001730. The vials are packaged in cartons of 20 and have specific expiration dates.
Look for the lot numbers listed in the recall notice: P0001370 through P0001730.
If you have a vial with a recalled lot number, stop using it immediately to prevent injury.
The vials can break and send glass flying when pressurized during preparation for injection, which may cause cuts or lacerations to healthcare workers.
If you have a vial with a recalled lot number, stop using it immediately and contact Exela Pharma Sciences for further instructions.
No, patients receiving the injection are not at risk from this vial breakage hazard as it occurs during preparation by healthcare professionals.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0022-2023 — Exela Exela Hello, I own a Exela that is covered by recall D-0022-2023 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.
