FDAClass IIApril 14, 2021

Neomycin Sulfate Tablets recall

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC…

Why was Neomycin Sulfate Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # CFMBX, EXP 9/2022

Product
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC…
Recalling firm
X-Gen Pharmaceuticals Inc.
Quantity
720 100-count (10x10 blister strips)
Distribution
Distributed Nationwide in the USA
Recall date
April 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls