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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: September 15, 2018
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Summary

Baxter Healthcare Corporation is recalling 5,184 bags of 0.9% Sodium Chloride Injection USP (sterile saline solution), sold in 50 mL Viaflex containers, due to deviations from Current Good Manufacturing Practice (cGMP). These manufacturing failures can compromise the quality and safety of the medication, which is commonly used for intravenous hydration or to dilute other medications before administration. The recall affects specific units from lot P380063 with an expiration date of December 2019. Consumers and healthcare providers should check their supplies immediately and contact their pharmacist for a refund and guidance.

Risk

The manufacturing deviations mean the sterile solution may not have been produced under the required quality-controlled conditions, potentially leading to contamination or safety risks for patients receiving the injection. Using non-compliant injectable drugs can lead to serious adverse health consequences, including infections or adverse inflammatory reactions.

What You Should Do

  1. Check your medical supplies for 0.9% Sodium Chloride Injection USP 50 mL Viaflex containers with NDC 0338-0049-31.
  2. Verify the lot number and expiration date on the packaging to see if they match lot P380063 with an expiration date of December 2019 (12/2019).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or were administered product from this affected lot.
  4. Return any unused product from lot P380063 to the pharmacy or place of purchase for a refund.
  5. Contact Baxter Healthcare Corporation directly for further instructions regarding the return process or if you have questions about the recall.
  6. For additional information, you can contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull 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 50 mL Viaflex container
Model:
NDC 0338-0049-31
Recall #: D-1190-2018
Lot Numbers:
P380063 (Exp. 12/2019)
Date Ranges: Expiration Date: 12/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80976
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Pharmacies; Healthcare facilities
Manufactured In: United States
Units Affected: 5184 bags
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 ยท 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.