Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: 0.9% Sodium Chloride Injection Recalled for Manufacturing Deviations

Agency Publication Date: August 27, 2018

Summary

Baxter Healthcare Corporation is recalling 33,600 bags of 0.9% Sodium Chloride Injection USP (100 mL) due to Current Good Manufacturing Practice (CGMP) deviations. This prescription medication, commonly known as saline solution, is used for fluid and electrolyte replacement and as a priming solution in hemodialysis. The recall was initiated because the products may not have been manufactured according to required quality standards, which could compromise the safety or effectiveness of the drug. These products were distributed specifically to facilities in Texas and Mississippi.

Risk

The deviations from good manufacturing practices mean the product may not meet its required quality or safety specifications. While no specific injuries or adverse events have been reported, using medication that fails to meet quality standards could lead to ineffective treatment or unexpected reactions.

What You Should Do

Check your medical supplies for 100 mL bags of 0.9% Sodium Chloride Injection USP (NDC 0338-0049-18) specifically labeled with lot number P380287 and an expiration date of 12/2019.
Immediately stop using any saline bags that match the affected lot number P380287.
Contact your healthcare provider or pharmacist for guidance if you have been administered this product or have it in your possession.
Return any unused product to the pharmacy or medical facility where it was obtained for a refund and contact Baxter Healthcare Corporation for further instructions.
Healthcare professionals and consumers should report any adverse reactions or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.
For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 0.9% Sodium Chloride Injection USP (100 mL bags)

Model:

NDC 0338-0049-18

Recall #: D-1128-2018

Lot Numbers:

P380287 (Exp. date 12/2019)

Date Ranges: December 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80881

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 33600 bags

Distributed To: Texas, Mississippi

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

Check your medical supplies for 100 mL bags of 0.9% Sodium Chloride Injection USP (NDC 0338-0049-18) specifically labeled with lot number P380287 and an expiration date of 12/2019.

Immediately stop using any saline bags that match the affected lot number P380287.

Contact your healthcare provider or pharmacist for guidance if you have been administered this product or have it in your possession.

Return any unused product to the pharmacy or medical facility where it was obtained for a refund and contact Baxter Healthcare Corporation for further instructions.

Healthcare professionals and consumers should report any adverse reactions or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.

For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).