X-Gen Pharmaceuticals Inc.

3 FDA enforcement actions

3 Total Recalls

0 Class I

1 Class II

2 Class III

Firm Details

Product Types: drug
States: NY

All Recalls

Class III: Low Risk 04/02/2024 drug

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 III: Low Risk 04/02/2024 drug

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 II: Risk 03/19/2021 drug

Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.