Home / Recalls / X-Gen Pharmaceuticals Inc. / D-0434-2024

D-0434-2024 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 10, 2024
Initiation Date
April 2, 2024
Termination Date
September 30, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1332 vials

Product Description

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 infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.

Reason for Recall

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 Pattern

Nationwide in the US

Code Information

Lot #: CIC2-23001 A, Exp. 11/30/2026

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-0328-2021 Class II — Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manu (March 19, 2021)
  • 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)