Sagent Pharmaceuticals, Inc.
Overview
Sagent Pharmaceuticals, Inc. is a leading developer, manufacturer, and marketer of pharmaceutical products with a focus on injectable drugs. As a subsidiary of Nichi-Iko Pharmaceutical Co., Ltd., Sagent emphasizes quality and innovation in producing essential medicines for healthcare providers.
Therapeutic areas
FDA compliance signals
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
Procedures not in writing, fully followed
- 4832019-12-18
SOPs not followed / documented
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