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FDAFDA · Food and drugs·Recall number D-0328-2021

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5

Published April 14, 2021 · Recall initiated: March 19, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
X-Gen Pharmaceuticals Inc.
Distributor
Distributed Nationwide in the USA
Lot
Lot # CFMBX, EXP 9/2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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