Horseheads, NY, United States
X-Gen Pharmaceuticals Inc. recalls
4 recalls recorded since 2018, most recently on 2 April 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 2 April 2024
- Terminated
- 30 September 2025
- Reason
- 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'.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0434-2024, D-0433-2024
- Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous
- Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Terminated Class II Drugs
- Recall started
- 19 March 2021
- Terminated
- 7 December 2022
- Reason
- Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0328-2021
- 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
Terminated Class III Drugs
- Recall started
- 11 October 2019
- Terminated
- 16 August 2022
- Reason
- Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0519-2020
- Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals
Terminated Class III Drugs
- Recall started
- 29 March 2019
- Terminated
- 2 June 2021
- Reason
- Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1084-2019
- Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.