FDA recall D-0328-2021

X-Gen Pharmaceuticals Inc. · Class II · drug

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

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-03-19
Report date: 2021-04-14
Termination date: 2022-12-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horseheads, NY, United States

Primary source

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