FDA Alert: Greenpark Compounding Pharmacy Products Lack Sterility Assurance

IPSIS Patient Safety Alert 09/17/2021: FDA Alerts Patients and Health Care Professionals Not to Use Greenpark Compounding Pharmacy Compounded Products Intended to Be Sterile

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.

ISSUE: The U.S. Food and Drug Administration (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.

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, the 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. Click here for more information.

The FDA is not aware of any adverse reactions associated with the use of compounded drugs from Greenpark Compounding Pharmacy.

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 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 Adverse Event Reporting Program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178
  

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