X-Gen Pharmaceuticals Inc.: Drug Recall

Recall Details

Recall Number

D-0328-2021

Classification

Class II

Product Type

Drug

Recalling Firm

X-Gen Pharmaceuticals Inc.

Status

Terminated

Date Initiated

03/19/2021

Location

Horseheads, NY, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

720 100-count (10x10 blister strips)

Reason for Recall

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

Product Description

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

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by X-Gen Pharmaceuticals Inc.

• Class III: Low Risk 04/02/2024
  Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
• Class III: Low Risk 04/02/2024
  Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

View all recalls by X-Gen Pharmaceuticals Inc. →