A Texas man pleaded guilty Tuesday to one count of adulterating a drug that was used in cataract surgeries.
According to court documents, Jack Randall Munn, 71, of Dallas, a licensed pharmacist and former owner of Guardian Pharmacy Services (Guardian), a Dallas pharmacy, oversaw the compounding of the drug for two outpatient Dallas surgical centers in 2016 and 2017. The drug, a combination of an antibiotic and a steroid, contained an excessive amount of an inactive ingredient that can damage sensitive eye tissue.
At the time of the events described in court documents, Munn represented to the surgical centers that Guardian could compound the drug in a manner safe for injection into patients’ eyes. However, the drug made by Guardian contained an excessive amount of the inactive ingredient, causing its purity and quality to fall below that which it was represented to possess.
Munn pleaded guilty to one misdemeanor count of distributing an adulterated drug in violation of the Federal Food Drug and Cosmetic Act. He is scheduled to be sentenced on Feb. 3, 2022 and faces a maximum penalty of one year in prison and a fine of up to $100,000. The federal magistrate judge who presided over Munn’s guilty plea will determine sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations investigated the case.
Assistant Director John Claud, Senior Trial Counsel David A. Frank and Trial Attorney Sarah Williams of the Civil Division’s Consumer Protection Branch are prosecuting the case. Associate Chief Counsel for Enforcement Karen Towns with the FDA’s Office of Chief Counsel, and the U.S. Attorney’s Office for the Northern District of Texas provided valuable assistance in the case.