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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

X-Gen Pharmaceuticals Inc.: Neomycin Sulfate Tablets Recalled for Failed Stability Testing

Agency Publication Date: April 8, 2021
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Summary

X-Gen Pharmaceuticals Inc. has recalled 720 units of Neomycin Sulfate Tablets, USP 500mg, because the medication failed stability specifications during a microbiological assay. This means the drug may not maintain its required potency or quality through its expiration date. Neomycin sulfate is a prescription antibiotic typically used to reduce the risk of infection during surgery or to treat certain hepatic conditions. Consumers should be aware that about 720 100-count blister packs are affected and were distributed nationwide.

Risk

The drug failed a microbiological assay, which indicates the product may not meet its required purity or strength standards over time. If a medication is less effective than expected, it could lead to untreated infections or inadequate preparation for surgical procedures.

What You Should Do

  1. Check your medication packaging for Neomycin Sulfate Tablets, USP 500mg (NDC 39822-0310-5) in 10x10 unit dose blister strips (100 tablets total).
  2. Confirm if your product is affected by looking for Lot # CFMBX with an expiration date of 9/2022.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if necessary.
  4. Return any unused tablets from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact X-Gen Pharmaceuticals Inc. at their Horseheads, NY facility or through their distributor at 300 Daniel Zenker Dr, Horseheads, NY 14845-1014 for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

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

Affected Products

Product: Neomycin Sulfate Tablets, USP 500mg (100-count / 10x10 unit dose)
Model:
NDC 39822-0310-5
Recall #: D-0328-2021
Lot Numbers:
CFMBX (Exp 9/2022)
Date Ranges: Expiration date 9/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87500
Status: Resolved
Manufacturer: X-Gen Pharmaceuticals Inc.
Manufactured In: United States
Units Affected: 720 100-count (10x10 blister strips)
Distributed To: Nationwide
Agency Last Updated: February 25, 2025

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.