FDA Warns Consumers Against Use of Texas Compounder’s Sterile Products

The FDA has issued a warning to patients and healthcare professionals against using sterile drugs from Richardson, Tex.-based North American Custom Laboratories, doing business as FarmaKeio Superior Custom Compounding.

The agency issued the alert following an inspection of the Texas facility in which an agency investigator observed conditions that could cause drug contamination, which the agency said could lead to “life-threatening adverse health effects, including infections and sepsis.”

The agency has recommended that the company issue a recall of all unexpired drugs that are intended to be sterile and that it cease all sterile operations until corrective actions are taken.

The company told FDAnews yesterday that it has not yet issued a recall.