Medications & Supplements/Prescription Drugs

8.4% Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: January 13, 2022

Summary

Exela Pharma Sciences LLC is recalling 18,960 vials of 8.4% Sodium Bicarbonate Injection, USP (sodium bicarbonate) because the company cannot guarantee the products are sterile. This recall affects 50 mL vials with NDC 51754-5001-1, which were distributed nationwide to hospitals, clinics, and pharmacies. No incidents or injuries have been reported in connection with this issue.

Risk

Injecting a drug that lacks assurance of sterility poses a high risk of serious or life-threatening infections, as the product is delivered directly into the patient's system. Because this medication is often used in emergency or critical care settings, patients may already be vulnerable to complications.

What You Should Do

This recall affects 50 mL vials of 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL) manufactured and distributed by Exela Pharma Sciences, LLC.
Check your supply for 50 mL vials labeled with NDC 51754-5001-1 and lot numbers C0001088/P0001317 or C0001088, with an expiration date of 08/2023.
Stop using the recalled product immediately and quarantine any remaining vials to prevent their use in clinical settings.
Contact the manufacturer, Exela Pharma Sciences LLC, or your medical distributor to arrange for the return of any affected vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further assistance or to report any adverse reactions.

Your Remedy Options

Other Action

Quarantine and return to manufacturer.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP (50 mL)

Variants: 50 mEq/50 mL (1 mEq/mL), Rx Only

Lot Numbers:

C0001088/P0001317 (Exp. 08/2023)

C0001088

NDC:

51754-5001-1

Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89402

Status: Resolved

Manufacturer: Exela Pharma Sciences LLC

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 18,960 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects 50 mL vials of 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL) manufactured and distributed by Exela Pharma Sciences, LLC.

Check your supply for 50 mL vials labeled with NDC 51754-5001-1 and lot numbers C0001088/P0001317 or C0001088, with an expiration date of 08/2023.

Stop using the recalled product immediately and quarantine any remaining vials to prevent their use in clinical settings.

Contact the manufacturer, Exela Pharma Sciences LLC, or your medical distributor to arrange for the return of any affected vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further assistance or to report any adverse reactions.