[6/21/2019] The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of all unexpired compounded drugs intended to be sterile produced by Infusion Options, Inc. of Brooklyn, N.Y., due to lack of sterility assurance and other significant quality issues. These drugs may pose a safety risk to patients.
Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections or death.
Health care professionals should immediately check their medical supplies, quarantine any drugs prepared by Infusion Options, and not administer or provide them to patients. FDA urges health care professionals, who obtained products from Infusion Options, to make alternative arrangements to obtain medications from sources that adhere to proper quality standards. Patients who have received any drug produced by Infusion Options and have concerns should contact their health care professional.
FDA investigators most recently inspected Infusion Options’ Brooklyn facilities in May and June of 2019 and observed conditions that could cause Infusion Options’ drugs to become contaminated or otherwise pose risks to patients.
On June 14, Infusion Options agreed to voluntarily recall all unexpired drug products intended to be sterile, cease sterile operations until the company takes adequate corrective actions and voluntarily destroy all drugs and drug components with FDA officials present, following FDA’s recommendations.
To date, FDA is not aware of any reports of illness associated with the use of Infusion Options’ drugs. The agency asks health care professionals and patients to report unexpected side effects or quality problems associated with Infusion Options’ drugs to FDA’s MedWatch Adverse Event Reporting program: