American Regent, Inc.
Overview
American Regent, Inc. is a pharmaceutical company headquartered in Shirley, United States, founded in 1910, with 501-1,000 employees.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class I2026-09-16
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class II2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- recall — Class I2026-08-26
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- 4832026-06-18
Procedures not in writing, fully followed
- recall — Class III2026-05-06
Labeling: Missing Label
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