Home / Recalls / X-Gen Pharmaceuticals Inc. / D-0328-2021

D-0328-2021 Class II Terminated

Recalled by X-Gen Pharmaceuticals Inc. — Horseheads, NY

Recall Details

Product Type
Drugs
Report Date
April 14, 2021
Initiation Date
March 19, 2021
Termination Date
December 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
720 100-count (10x10 blister strips)

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

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # CFMBX, EXP 9/2022

Other recalls by X-Gen Pharmaceuticals Inc.

  • D-0433-2024 Class III — Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, S (April 2, 2024)
  • D-0434-2024 Class III — Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Dis (April 2, 2024)
  • D-0519-2020 Class III — Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufact (October 11, 2019)
  • D-1084-2019 Class III — Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx (March 29, 2019)
  • D-1059-2017 Class II — Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, R (May 17, 2017)
  • D-0637-2017 Class I — Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39 (February 8, 2017)
  • D-1444-2014 Class III — Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx (July 17, 2014)