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FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy

[9/29/2021] Update: FDA is alerting veterinarians and animal owners/caretakers not to use compounded products intended to be sterile from Greenpark Compounding Pharmacy. Animal owners/caretakers who have received compounded drugs produced by Greenpark Compounding Pharmacy and have concerns should contact their veterinarian as appropriate. 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.

[9/17/2021] 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, Houston, Texas, 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.

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.

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.

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. 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.

Patients who have received compounded drugs produced by Greenpark Compounding Pharmacy and have concerns should contact their health care professional.

FDA is not aware of any adverse reactions associated with the use of compounded drugs from Greenpark Compounding Pharmacy. FDA encourages health care professionals and patients to report adverse reactions or quality problems experienced with the use of these drugs to the FDA’s MedWatch Adverse Event Reporting program:

 
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