Exela Pharma Sciences LLC

10 FDA enforcement actions

10 Total Recalls

7 Class I

3 Class II

0 Class III

Firm Details

Product Types: drug
States: NC

All Recalls

Class II: Risk 07/30/2025 drug

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II: Risk 03/07/2025 drug

Lack of Assurance of Sterility
Class I: Dangerous 10/18/2023 drug

Presence of Particulate Matter: Silicone
Class I: Dangerous 10/18/2023 drug

Presence of Particulate Matter: Silicone
Class I: Dangerous 10/18/2023 drug

Presence of Particulate Matter: Silicone
Class I: Dangerous 11/28/2022 drug

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I: Dangerous 11/28/2022 drug

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I: Dangerous 10/04/2022 drug

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I: Dangerous 10/04/2022 drug

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class II: Risk 01/11/2022 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.