FDA-Drug2021-04-14Class II

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

X-Gen Pharmaceuticals Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
720 100-count (10x10 blister strips)
Manufactured in
300 Daniel Zenker Dr, N/A, Horseheads, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0328-2021

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