US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 19, 2021 (5 years ago)

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
X-Gen Pharmaceuticals Inc.
NDC code
39822-0310-5
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0328-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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