X Gen Pharmaceuticals Inc Recalls

Cyclophosphamide 500mg Injection (X-Gen) – Labeling Error (2024)

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'.

Class IIILow

FDAApr 2, 2024Nationwide• X-Gen Pharmaceuticals Inc.

Cyclophosphamide 1g Injection (X-Gen) – Labeling Error (2024)

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'.

Class IIILow

FDAApr 2, 2024Nationwide• X-Gen Pharmaceuticals Inc.

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X-Gen Pharmaceuticals Inc. Recalls

Recall Summary

Cyclophosphamide 500mg Injection (X-Gen) – Labeling Error (2024)

Cyclophosphamide 1g Injection (X-Gen) – Labeling Error (2024)

Neomycin Sulfate Tablets (X-Gen) – Stability Failure (2021)

Levetiracetam Injection (X-Gen) – Incorrect Labeling (2019)

Clonidine HCL Injection (X-Gen) – Labeling Error (2019)

Nystatin Topical Powder (X-Gen Pharmaceuticals) – Plastic Particle Contamination (2017)

Ibuprofen Lysine Injection (X-Gen) – Particulate Matter (2017)

Clonidine HCl Injection (X-Gen) – labeling error (2014)