Sagent Pharmaceuticals, Inc.

34 FDA enforcement records linked to this company.

• recall — Class III2026-05-27

  Failed Impurities/Degradation Specifications

• recall — Class I2024-06-19

  Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

• recall — Class I2024-06-19

  Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

• recall — Class II2024-05-22

  Presence of Particulate Matter: Potential for black particulates in the drug product.

• recall — Class II2023-08-02

  Lack of Assurance of Sterility

• recall — Class II2023-08-02

  Lack of Assurance of Sterility

• recall — Class II2023-08-02

  Lack of Assurance of Sterility

• recall — Class II2023-05-31

  Lack of Assurance of Sterility

• recall — Class II2023-05-31

  Lack of Assurance of Sterility

• recall — Class II2023-05-31

  Lack of Assurance of Sterility

• recall — Class II2023-03-15

  Labeling: Not elsewhere classified

• recall — Class II2021-03-24

  Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

• 4832019-12-18

  Contract drug products--lack of responsibility

• 4832019-12-18

  Contamination, chemical or physical change, deterioration

• 4832019-12-18

  Procedures not in writing, fully followed