September 18, 2023: Eight companies, including two pharmacies, are illegally marketing unapproved risky ophthalmic eye drops

This week:  USFDA is concerned that eight companies, including two pharmacies, are illegally marketing unapproved ophthalmic drug products that pose a heightened risk to users. Counterfeit pills make the DHS’ threat assessment list for 2024.

Major Stories

Illegally marketed eyedrops in the U.S. and Canada. Homeland Security acknowledges risk of counterfeit pills in U.S.

The U.S. Food and Drug Administration warned eight companies to stop making or selling eye drops being illegally marketed to treat pink eye, cataracts, glaucoma and other eye ailments. The letters, some of which also cite quality issues with the drops, follow a warning about contaminated ophthalmic drug products in August.

At the same time, Health Canada warned residents not to buy or use nine different unauthorized health products, including eye drops, cold medicine, an iron supplement and ointments seized from a store in Richmond, British Columbia. 

Counterfeit prescription pills and illegal pill presses have made the Department of Homeland Security’s threat assessment list for 2024. The Intelligence Enterprise Homeland Threat Assessment 2024 published by the Department of Homeland Security reports, “Traffickers in Mexico and the United States are using various additives, such as xylazine, and mixing fentanyl into counterfeit prescription pills, which are driving an increase in overdoses.” 


Learn what regulators are saying about drops you shouldn't be putting in your eyes. 

States the report, “Domestic drug traffickers have gained more influence over the composition of fentanyl pills available in the United States and have distributed potentially more deadly mixtures of the drug to both witting and unwitting users. US law enforcement seizures of pill presses purchased online have increased, suggesting these US‑based traffickers are pressing a highly toxic combination of drugs into different types of pills. Fentanyl has appeared more frequently in counterfeit prescription pills, such as Adderall and Xanax, combinations that raise the risk of overdose, particularly for unwitting users. Traffickers are also bulking fentanyl powder and pills with the animal sedative xylazine (‘Tranq’), challenging standard opioid overdose treatments.”

Courtesy of Homeland Security

International News

Counterfeit pills plague the globe from Canada around to Australia, and vary from fake NSAIDS to fakes containing benzodiazepines or amphetamines.

Internationally, the Philippines’ Food and Drug Administration warned residents about eight kinds of counterfeit prescription antidiarrheals and NSAIDS found in circulation. 

Almost 1 million doses of counterfeit diazepam and a pill press were seized in Scotland

The United Arab Emirates announced the seizure of over 28,000 pounds of counterfeit Captagon pills hidden in a shipment of doors and decorative building panels. 

In Australia, a woman in Melbourne pleaded guilty after charges of using a pill press to make counterfeit Xanax in her home. Authorities also seized a pill press in Port Lincoln, South Australia

Canadian authorities sentenced two British Columbian residents to 11 years in prison each for making fentanyl, methamphetamine, and steroids in what was characterized as a “drug super lab” when law enforcement busted it in October 2018.

Domestic News

Domestic deaths, prosecutions, convictions and seizures involving fentanyl-based counterfeit pills support the Department of Homeland Security's conclusion that counterfeit pills are a continuing threat to Americans.

Teymour Peters of Rockville, Maryland will serve 19 months in prison for manslaughter after he sold fellow Rockville resident Kevin Ourand the fake oxycodone pill made with fentanyl that killed him in October 2022.

Timothy Clark Wolfe received a 14-year prison sentence for selling 19-year-old Emilio Velci of Atascadero, California counterfeit oxycodone pills made with fentanyl, one of which killed him in March 2020

People in Memphis, Tennessee, and St. Paul, Minnesota were charged in counterfeit pill deaths. People were convicted or sentenced in cases involving counterfeit pills in Wichita, Kansas; Kentucky’s Graves, Carlisle, and Hickman counties; Boston, Massachusetts; Havre and Missoula (1, 2), Montana and Cheyenne, Wyoming. 

Families in Minnesota, North Carolina and Tennessee spoke of the pain of losing children to counterfeit pills containing fentanyl.

Authorities seized two commercial grade pill presses from a home in Lake Charles, Louisiana in the second week of September.

The California Highway Patrol seized more than 107 pounds of fentanyl-laced pills hidden in a spare tire during a traffic stop in Fresno County.

A police task force in Phoenix, Arizona arrested two men and seized 130,000 fentanyl pills hidden in a pickup driving around a commercial parking lot. The men had allegedly arranged a sale with a confidential informant.

Detectives with Fairfax County, Virginia’s Organized Crime and Narcotics announced the August seizure of over 84,000 units of illegal drugs, including over 2,500 fentanyl and other opiate pills, as well as $154,000.

Counterfeit pills, including fentanyl pills and fake Xanax, were also confiscated in Monterey, California; Steamboat Springs, Colorado; Muncie, Indiana; Wichita, Kansas; and Frankenlust Township, Michigan.