Reported Apr 14, 2021 · Terminated

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc.…

X-Gen Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Dr · Horseheads, NY · 14845-1014

Is this the product you have?

  • Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets
  • Manufactured forX-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
Lot codes and dates
  • Lot # CFMBX, EXP 9/2022
Amount recalled
720 100-count (10x10 blister strips)

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 7, 2022 · Data as of Sep 19, 8:07 PM UTC

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