Unrated Drug recall · FDA · Published January 11, 2022

Exela 8.4% Sodium Bicarbonate Injection Recall: Lack of Sterility Assurance

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0369-2022Drug Exela ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmExela Pharma Sciences LLC1245 Blowing Rock Blvd · Lenoir, NC 28645-3618

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/35389-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/35389-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility · Updated August 18, 2026 · FDA enforcement record: FDA #D-0369-2022

Cite this page

“Exela 8.4% Sodium Bicarbonate Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35389-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility. Based on FDA recall #D-0369-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0369-2022%22&limit=1).

Exela Pharma Sciences LLC voluntarily recalled 8.4% Sodium Bicarbonate Injection vials due to a lack of sterility assurance, according to the FDA on Jan. 11, 2022. The recall affects 18,960 units distributed nationwide.

How to tell if you have it

Brand: Exela
Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials
NDC: 51754-5001-1
Lot Codes: C0001088/P0001317
Expiration Date: 08/2023

The hazard

The product poses a risk due to a lack of assurance of sterility. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Exela Pharma Sciences LLC has 7 other recalls on record since April 20, 2018. Other recent recalls of similar products include Fresenius Kabi 1000mL Sodium Chloride Injection Recall (March 11, 2026), Fresenius Kabi 0.9% Sodium Chloride Injection Recall (March 11, 2026), and Huons Co. 10mL Sodium Chloride Injection Recall (April 2, 2026).

How to tell if you have this one

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.

Brand
Exela
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product label includes NDC 51754-5001-1 and lot numbers C0001088/P0001317.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Jan 11, 2022Firm started the recall
Jan 13, 2022FDA classified it Class II
Jan 19, 2022Published in FDA’s Enforcement Report
Dec 2, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/35389-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility">Exela 8.4% Sodium Bicarbonate Injection Recall: Lack of Sterility Assurance (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #D-0369-2022 (January 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0369-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.