American Regent, Inc.

7 FDA enforcement actions

7 Total Recalls

0 Class I

7 Class II

0 Class III

Firm Details

Product Types: drug
States: OH, NY

All Recalls

Class II: Risk 04/18/2025 drug

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 04/18/2025 drug

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 11/11/2024 drug

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024 drug

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024 drug

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility.
Class II: Risk 05/13/2024 drug

Subpotent product in addition to having out-of-specification results for impurities.

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.