Other safety alerts
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| The United States: FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding |
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The US Food and Drug Administration (FDA) announces that it is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding, due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis.
FDA investigators recently inspected FarmaKeio Superior Custom Compounding’s facility and observed conditions that could cause the drugs produced by the company to become contaminated or otherwise pose risks to patients. FDA recommended the company voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, the company has not initiated a recall.
To date, FDA is not aware of any reports of illness associated with the use of FarmaKeio Superior Custom Compounding’s drugs.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company.
Ends/Thursday, Mar 31, 2022
Issued at HKT 15:00
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