The FDA said Sept. 17 that investigators inspected the compounding pharmacy in July and August and found conditions which could cause the compounded drugs to be contaminated or otherwise pose risks to patients.
Using non-sterile drug products that are intended to be sterile could cause serious, potentially life-threatening infections or death, the agency warned.
Greenpark recalled several lots of its compounded ophthalmic drugs in August. The FDA later recommended the pharmacy expand its recall to all unexpired compounded drugs intended to be sterile and to stop production until it implements corrective actions, but the pharmacy has refused to do so, according to the agency.
Healthcare providers and patients should check their medical supplies and immediately stop using any products marketed as sterile from Greenpark Compounding Pharmacy, the FDA said.
The agency isn’t aware of any adverse reactions to Greenpark’s compounded drug products.
Read the FDA’s full news release here.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
