X-Gen Pharmaceuticals recalls
FDA enforcement reports naming X-Gen Pharmaceuticals Inc. as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 1
- Most recent report
- Apr 10, 2024
- Apr 10, 2024Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single D…Drug · X-Gen Pharmaceuticals Inc.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…Class III
- Apr 10, 2024Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard un…Drug · X-Gen Pharmaceuticals Inc.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…Class III
- Apr 14, 2021Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufacture…Drug · X-Gen Pharmaceuticals Inc.Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assayClass II
- Nov 27, 2019Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by…Drug · X-Gen Pharmaceuticals Inc.Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.Class III
- Apr 17, 2019Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, M…Drug · X-Gen Pharmaceuticals Inc.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.Class III
- Aug 16, 2017Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only,…Drug · X-Gen Pharmaceuticals Inc.Presence of Foreign Substance: potential presence of plastic particles.Class II
- Apr 12, 2017Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-103…Drug · X-Gen Pharmaceuticals Inc.Presence of Particulate MatterClass I
- Jul 30, 2014Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, M…Drug · X-Gen Pharmaceuticals Inc.Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".Class III