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X-Gen Pharmaceuticals Recalls
8 recalls on record · July 30, 2014 to April 10, 2024 · Drugs
Recalls by year
14
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19
21
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 10, 2024DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, A
Hazard: 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'.
April 10, 2024DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx
Hazard: 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'.
April 14, 2021DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc.
Hazard: Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
November 27, 2019DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limit
Hazard: Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
April 17, 2019DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut
Hazard: 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.
August 16, 2017DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Hazard: Presence of Foreign Substance: potential presence of plastic particles.
April 12, 2017DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single
Hazard: Presence of Particulate Matter
July 30, 2014DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut
Hazard: 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".