FDA MedWatch - UPDATE: Compounded Products for Use in Humans and Animals Intended to be Sterile by Greenpark Compounding Pharmacy:

CDER Alert - FDA Alerts Patients, Health Care Professionals, Veterinarians, and Animal Owners/Caretakers Not to Use

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: UPDATE: Compounded Products Intended to be Sterile by Greenpark Compounding Pharmacy: CDER Alert - FDA Alerts Patients, Health Care Professionals, Veterinarians, and Animal Owners/Caretakers Not to Use AUDIENCE: Patient, Consumer, Health Professional, Risk Manager, Veterinary Medicine 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 is not aware of any adverse reactions associated with the use of compounded drugs from Greenpark Compounding Pharmacy. For more information about this alert, click on the red button "Read Alert" below. BACKGROUND: FDA investigators 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. 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. This applies to both human and veterinary drugs produced by Greenpark. RECOMMENDATIONS:  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 and animal owners/caretakers who have received compounded drugs produced by Greenpark Compounding Pharmacy and have concerns should contact their health care professional/veterinarian. 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: Veterinarians and animal owners/caretakers can report adverse events or side effects related to the use of these products. Please visit How to Report Animal Drug and Device Side Effects and Product Problems for more information. 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.

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