Drug & medication recalls Moderate risk

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

Recall date
March 19, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0328-2021
FDA classification
Class II
Brand / firm
X-Gen Pharmaceuticals Inc.
Sold / distributed
Distributed Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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