Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to reported breakage and glass flying when pressurized during administration. Affected lots expire through December 2023.
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 poses a serious risk of injury to healthcare workers handling the vials.
The vials can break and cause glass fragments to fly when pressurized during preparation for injection. This creates a risk of serious injury to healthcare workers who handle the vials, such as cuts or lacerations from flying glass.
Healthcare professionals using the recalled vials for medical administration are most at risk. Patients receiving the injection would not be directly affected since the vials are only used by medical staff.
Check for vials with the NDC 51754-5001-1. The product was sold in cartons of 20 vials with specific expiration dates through December 2023.
Discard any recalled vials that have broken or show signs of damage.
Reach out to Exela Pharma Sciences for further guidance on safe handling or alternatives.
No, the recalled vials can break and send glass flying when pressurized during medical use, posing a serious injury risk.
The recalled vials have expiration dates through December 2023, with specific lots listed in the recall notice.
Look for vials with NDC 51754-5001-1 in cartons of 20, which were manufactured with specific expiration dates through December 2023.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0079-2023 — Exela Exela Hello, I own a Exela that is covered by recall D-0079-2023 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.
