Exela Pharma Sciences Llc

27 FDA enforcement records linked to this company.

• recall — Class II2025-09-17

  Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

• warning_letter2025-07-02

  FDA Warning Letter (drug product)

• recall — Class II2025-04-02

  Lack of Assurance of Sterility

• recall — Class I2023-11-29

  Presence of Particulate Matter: Silicone

• recall — Class I2023-11-29

  Presence of Particulate Matter: Silicone

• recall — Class I2023-11-29

  Presence of Particulate Matter: Silicone

• recall — Class I2022-12-21

  Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

• recall — Class I2022-12-21

  Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

• recall — Class I2022-11-02

  Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

• recall — Class I2022-11-02

  Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

• recall — Class II2022-01-19

  Lack of Assurance of Sterility

• warning_letter2021-04-09

  FDA Warning Letter (drug product)

• recall — Class III2020-09-23

  Short Fill

• 4832019-07-18

  Containers & Closures Clean, Sterilized, Pyrogen-free

• 4832019-07-18

  Prepared for each batch, include complete information