Sagent Pharmaceuticals

6 FDA enforcement actions

6 Total Recalls

2 Class I

4 Class II

0 Class III

Firm Details

Product Types: drug
States: IL

All Recalls

Class I: Dangerous 05/28/2024 drug

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I: Dangerous 05/28/2024 drug

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II: Risk 04/25/2024 drug

Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II: Risk 07/11/2023 drug

Lack of Assurance of Sterility
Class II: Risk 07/11/2023 drug

Lack of Assurance of Sterility
Class II: Risk 07/11/2023 drug

Lack of Assurance of Sterility

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.