A pharmacist admits to putting an eye-damaging chemical in a cataract surgery drug.
A Texas pharmacist has admitted to putting a substance in a medicine used during cataract surgery that could cause lasting damage to the eyes.
Jack Randall Munn, 71, of Dallas, Texas, pled guilty on Wednesday to one count of misdemeanor distribution of an adulterated drug in violation of the Federal Food, Drug, and Cosmetic Act. Munn faces a potential sentence of one year in prison and a fine of up to $100,000 when he is sentenced on February 3, 2022.
After examining the US Sentencing Guidelines and other relevant considerations, a federal magistrate will determine the punishment.
Munn, a certified pharmacist and the former proprietor of Guardian Pharmacy Services (Guardian) in Dallas, Texas, was in charge of monitoring the cataract medicine for two outpatient Dallas surgical centers in 2016 and 2017, according to a court affidavit. The medicine, which is a mix of antibiotics and steroids, contains a substantial amount of an inactive component that might harm fragile eye tissue.
Munn asserted later in the court affidavit that Guardian could make the medicine in a safe manner that could be injected into patients’ eyes. However, because the Guardian medicine contained a substantial amount of the inactive ingredient, the overall quality of the drug deteriorated, making it dangerous to deliver to patients.
The FDA’s Office of Criminal Investigations investigated the case, which is being prosecuted by Assistant Director John Claud, Senior Trial Counsel David A. Frank, and Trial Attorney Sarah Williams of the Civil Division’s Consumer Protection Branch.
In a similar case, a New Jersey chiropractor pled guilty in June to illegally marketing “steroid-like medicines” while running a nutritional supplement company, according to the FDA’s Office of Criminal Investigations.
Nicholas Andrew Puccio, 41, of Columbus, New Jersey, admitted to Judge James P. Jones in the United States District Court for the Western District of Virginia on June 10 that he intentionally misled and cheated consumers and the FDA by developing an unapproved new medicine for commerce. Puccio also sold bodybuilders and others in the “fitness community” products containing ostarine, one of several compounds that imitate steroids and are known as selective androgen receptor modulators (SARMs). Marketing has a bad reputation. This is a condensed version of the information.