Compounded Drug Recall

TOPIC: Compounded Products Intended to be Sterile by Greenpark Compounding Pharmacy: CDER Alert - FDA Alerts Patients and Health Care Professionals Not to Use AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: FDA is alerting patients and health care professionals not to use compounded products intended to be sterile, produced and distributed nationwide by Prescription Labs Inc. doing business as Greenpark Compounding Pharmacy due to lack of sterility assurance. Administration of non-sterile products intended to be sterile may result in serious and potentially life-threatening infections or death. FDA investigators recently inspected Greenpark Compounding Pharmacy’s facility during July and August 2021 and observed conditions which could cause the compounded drugs to be contaminated or otherwise pose risks to patients. For more information about this alert, click on the red button "Read Alert" below. BACKGROUND: On August 18 and August 31, 2021, the compounder initiated a recall of several lots of a compounded ophthalmic drug. On September 2, 2021, 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. FDA is not aware of any adverse reactions associated with the use of compounded drugs from Greenpark Compounding Pharmacy. RECOMMENDATION/S: Health care professionals and patients should immediately check their medical supplies, quarantine any products marketed as sterile from Greenpark Compounding Pharmacy, and not administer or provide them to patients. Patients who have received compounded drugs produced by Greenpark Compounding Pharmacy and have concerns should contact their health care professional. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Read Alert Button feed