Quarantine All Sterile Drugs from Compounder Medistat

All non-expired drugs produced for sterile use by Alabama-based compounder Medistat RX have been recalled due to potential contamination, the FDA is warning pharmacists.

Because contaminated drugs put patients at risk of serious and potentially life-threatening infections, health care professionals should immediately check their medication supplies for any drugs marketed as sterile from Medistat, and then quarantine those drugs to avoid administering them to patients.

The recalled products were distributed nationwide between November 1, 2014, and September 3, 2015, the FDA said.

Patients who have received any drugs produced by Medistat should contact their health care professional. The FDA encourages health care professionals and patients to report adverse reactions or quality problems related to these recalled products to its MedWatch program.

Medistat is registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act. It voluntarily ceased sterile compounding operations on September 1, 2015, after FDA investigators and Alabama inspectors observed significant deficiencies that raised concerns about the compounder’s ability to assure the sterility of the drugs it produced.

The FDA says it will continue to work closely with the Alabama Board of Pharmacy to protect the public health.