Cardinal Health
Overview
Cardinal Health is a medical device company headquartered in Elstead, United Kingdom, founded in 2009, with over 10,000 employees.
FDA compliance signals
50 FDA enforcement records linked to this company.
- 4832026-02-21
Record quality
- 4832026-02-21
Equipment
- recall — Class II2025-09-03
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
- 4832025-08-15
Master Production and Control Records
- 4832025-08-15
Lab sampling and test procedures
- recall — Class II2025-08-13
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- recall — Class II2025-08-13
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- recall — Class II2025-08-13
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- recall — Class II2025-05-07
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
- recall — Class I2023-11-29
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- recall — Class I2023-11-29
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- recall — Class I2023-11-29
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- recall — Class I2023-11-29
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- recall — Class I2023-11-29
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- recall — Class I2023-11-29
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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