FDA Safety Alert on Greenpark Compounded Drugs

An FDA safety alert warns healthcare professionals and patients not to use compounded products from Prescription Labs, doing business as Greenpark Compounding Pharmacy (Houston, TX), due to lack of sterility assurance. Using non-sterile products may result in serious and potentially life-threatening infections or death, the alert says.

FDA says it recently inspected the firm’s facility and documented conditions which could cause the compounded drugs to be contaminated. Last month, Greenpark recalled several lots of a compounded ophthalmic drug. “On 9/2, FDA recommended Greenpark Compounding Pharmacy expand its recall to all unexpired compounded drugs intended to be sterile and stop sterile production until it implements adequate corrective actions,” the agency says. “To date, the company has refused to recall all unexpired compounded drug products intended to be sterile or to cease compounding of all sterile drugs.”