X-Gen Pharmaceuticals Inc. recalls Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc.
Recalled April 14, 2021 · FDA recall D-0328-2021 · X-Gen Pharmaceuticals
Hazard
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay · FDA Class II
Units
720 100-count (10x10 blister strips)
Sold at
Distributed Nationwide in the USA
Description
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Product
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
Manufacturer(s)
X-Gen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →