MasterPharm Compounding Pharmacy — Did they Endanger Patients with FinPlus?
Years of Inspections, Reports, Letters from FDA Went Unheeded
MasterPharm Compounding Pharmacy in South Richmond Hill, N.Y., has recalled a “bad batch” of a drug called Finasteride Plus, known as FinPlus, that aids in hair growth.
The recall involves a lot of 1.25-milligram capsules marketed to consumers both commercially and via mail order that contain an accelerated level of an antihypertensive medication called minoxidil. That drug has caused a range of adverse events in patients throughout the South Florida area.
“Consumption of undeclared minoxidil would be expected to result in low blood pressure, rapid heartbeat, and salt and water retention causing swelling,” states a recall letter on the company’s Web site. “Consequently, patients may be at risk for developing heart failure or other heart damage. Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use. MasterPharm, LLC. has received 33 reports of increased heart rate, retention of water, dizziness and low blood pressure.”
In the South Florida area, specifically Boca Raton, about 70 patients have been negatively impacted by FinPlus, according to Searcy Denney Scarola Barnhart & Shipley attorney Brenda Fulmer.
“The product is a compounded drug for hair loss and is packaged in orange prescription bottles containing 30 capsules or blue prescription bottles containing 90 capsules,” the recall letter states. “The affected Finasteride Plus 1.25mg lots include the following 02-27-2020:04@11 and a Beyond Use Date of August 25, 2020. The product can be identified by the patient-specific labeled prescription bottles with product batch labels and a patient-specific prescription label. Finasteride Plus 1.25mg was distributed Nationwide on a patient-specific prescription basis only.
“MasterPharm, LLC. is notifying its customers by telephone, e-mail, and common carrier letters and is arranging for return and replacement of all recalled products,” it continues. “Consumers that have Finasteride Plus 1.25mg which is being recalled should stop using and return the Finasteride Plus 1.25mg to MasterPharm, LLC. self-addressed packaging from MasterPharm, LLC. that has been sent to all customers previously.”
The harsh reality of the health risks that led to the recall of FinPlus is that they could have been prevented. As far back as 2015, the U.S Food & Drug Administration (FDA) issued terse warning letters in response to written reports that followed multiday inspections at MasterPharm. The overlying issue was concerns about the company’s inadequate sterilization routines. An inspection in April / May of that year led to number of observations on deficient aseptic process areas, environment monitoring and disinfectant effectiveness studies and the possibility of cross contamination.
“No disinfectant effectiveness studies have been performed to determine if disinfection agents are effective in septic processing areas,” according to the FDA report. “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed. Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements. Your firm does not test every sterile drug lot produced for sterility or endotoxins. The separate or defined areas necessary to prevent contamination or mix-ups are deficient. There are no separate facilities, for processing operations, to prevent contamination from the beta-Lactam injectable drug that you process – Ceftazidime syringe. This beta-Lactam powder, which is contained in glass vials, is processed in the same ISO 5 hood as are sterile injectable non beta-Lactam drugs. There is no assurance that a potential breakage of the glass vial and consequent powder spill would not contaminate other sterile drug products.”
Here is an excerpt from the subsequent warning letter to MasterPharm CEO Steven Laddy.
“During the inspection, the investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk,” writes Ronald Pace, director of the FDA’s New York District Office. “Our investigator also noted that your firm did not use a sporicidal agent to disinfect the ISO 5 areas. Furthermore, our investigator found that your firm failed to demonstrate through appropriate studies that your aseptic work stations are able to provide adequate protection of the ISO 5 areas in which sterile products are processed. Therefore, your products may be produced in an environment that poses a significant contamination risk. Additionally, FDA testing found bacterial contamination in an unopened vial of Trimix injection prepared by your firm. Based on this inspection and testing, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).”
Another multiday inspection took place in January of 2017 that found MasterPharm failed “to conduct adequate aseptic process stimulation (APS)” and failed “to submit the vials produced from the APS for sterility testing in a timely manner.”
This time, the subsequent warning letter was sent to Kimberly Leonard, of the New York State Education Department’s Office of the Professions.
“During the inspection, the FDA investigator observed deviations from appropriate sterile practice standards that, if not corrected, could lead to contamination of drugs, potentially putting patients at risk,” writes Diana Amador-Toro, director of the FDA’s New Jersey District Office of Regulatory Affairs. “FDA does not intend to take further action at this time with regard to the findings of this inspection. This firm apparently obtains prescriptions for identified individual patients before distributing its compounded drugs, as required by section 503A(a) of the Federal Food, Drug and Cosmetic Act, and FDA believes that the corrective actions can be appropriately overseen by the State. Therefore, FDA is referring this matter to the New York State BOP for follow up to ensure appropriate corrective action is taken.”
Searcy Denney Scarola Barnhart & Shipley is investigating potential lawsuits involving patients in the South Florida area who received the contaminated hair-loss drugs from MasterPharm. The hair-loss drugs combined finasteride (the generic version of Propecia) and a blend of herbs, nutrients and vitamins intended to promote hair growth. The adulterated finasteride combination hair-growth drugs – FinPlus – were contaminated with minoxidil, another drug prescribed for hair regrowth but also is a powerful heart medication.
Symptoms reported by patients who have ingested finasteride from the “bad batch” include heart palpitations, extremely low blood pressure, fainting, dizziness, confusion, irregular heart rate, overwhelming fatigue, sweats and flushing, vomiting and shortness of breath. Such symptoms are consistent with an overdose of minoxidil, although an investigation is pending as to the nature and extent of the contamination of the finasteride medications.
If you or a loved one has taken finasteride combination hair-growth drugs distributed by MasterPharm, please contact our office for a free legal consultation.