Exela Pharma Sciences recalls 50mL sodium bicarbonate injection vials due to lack of sterility assurance. This medication is prescription-only and may pose infection risks if used.
Lack of Assurance of Sterility
Exela Pharma Sciences is recalling 50mL sodium bicarbonate injection vials because they lack sterility assurance. This means the product could cause infections if used improperly.
The injection vials were manufactured without proper sterility checks, which could lead to bacterial contamination. If the product is used without proper sterilization, it might cause infections in patients.
Prescription patients using this medication for medical purposes. Those with compromised immune systems are at higher risk.
Check for vials labeled '8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)' with NDC 51754-5001-1 and lot numbers C0001088/P0001317. The product expires August 2023.
Verify the product label includes NDC 51754-5001-1 and lot numbers C0001088/P0001317.
The recall states there is a lack of sterility assurance, so it may cause infections if used improperly. Do not use the product until the recall is resolved.
Look for vials labeled '8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)' with NDC 51754-5001-1 and lot numbers C0001088/P0001317.
The recall does not specify a remedy, so contact Exela Pharma Sciences 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-0369-2022 — Exela Exela Hello, I own a Exela that is covered by recall D-0369-2022 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.
