[5/25/2022] FDA is alerting customers of North American Custom Laboratories LLC, doing business as FarmaKeio Superior Custom Compounding’s voluntary recall, initiated on April 5, 2022, of unexpired drug products that are intended to be sterile. This recall includes the products FDA recommended the company voluntarily recall in March 2022. The company emailed recall letters to all patients who received the recalled drug products. Additional information regarding this recall can be found on FDA’s Enforcement Report.
[3/30/2022] FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, FarmaKeio Superior Custom Compounding, Richardson, TX, 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.
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. FDA urges health care professionals who obtained products from this company to make alternative arrangements to obtain medications from sources that adhere to proper quality standards. Patients who have received any drug produced by the company and have concerns should contact their health care professional.
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.
To date, FDA is not aware of any reports of illness associated with the use of FarmaKeio Superior Custom Compounding’s drugs. Health care professionals and patients should report unexpected side effects or quality problems associated with the company’s drugs to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.