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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Sterile Products by North American Custom Laboratories: CDER Alert - FDA Warns Patients and Health Care Professionals Not to Use
AUDIENCE: Patient, Health Professional
ISSUE: FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories, 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.
To date, FDA is not aware of any reports of illness associated with the use of FarmaKeio Superior Custom Compounding’s drugs.
For more information about this alert, click on the red button Read Alert below.
BACKGROUND: FDA investigators recently inspected FarmaKeio Superior Custom Compounding’s facility located at 1736 N. Greenville Ave., Richardson, TX, and observed conditions that could cause the drugs produced by the company to become contaminated or otherwise pose risks to patients. This company was inspected as a 503A pharmacy compounding facility. 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.
RECOMMENDATIONS:
- Patients who have received any drug produced by the company and have concerns should contact their health care professional.
- Health care professionals should immediately check their medical supplies, quarantine any drugs intending to be sterile and produced by FarmaKeio Superior Custom Compounding, and not administer or provide them to patients.
- Health care professionals who obtained products from this company should make alternative arrangements to obtain medications from sources that adhere to proper quality standards.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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