November 25, 2024: A new money laundering case is tied to online pharmacies selling counterfeit pills

November 25, 2024

A California man allegedly processed payments for foreign online pharmacies selling fentanyl and meth pills.

Read More

November 18, 2024: Regulators struggle with GLP-1s in the U.S. and abroad

November 18, 2024

Novo Nordisk filed five more lawsuits against businesses selling compounded semaglutide. Dr. Tim Mackey spoke about the dangers of the unregulated semaglutide sales online, and South Africa warned residents about counterfeit Ozempic.

Read More

FDA Alert: Dietary Supplement Recalled Due to Presence of Sildenafil and Diclofenac

November 14, 2024

Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

Read More

FDA Alert: Dietary Supplement Contains Drug That Can Cause Heart Attack, Stroke and Internal Bleeding

November 14, 2024

Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Read More
screenshot of a product listing on tradeford.com

November 11, 2024: Feds pursue companies selling fentanyl precursors

November 12, 2024

Another China-based chemical company was indicted for allegedly selling precursor chemicals and xylazine to U.S. buyers as Americans continue to grapple with the toll of counterfeit prescription pills made with dangerous drugs.

Read More

FDA Alert: Compounding Pharmacy in California Warned After Particulates Found in Injections

November 5, 2024

On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.

Read More

FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients

November 5, 2024

The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.

Read More

November 4, 2024: The FDA continues to work for patient safety

November 4, 2024

This week the agency warned about compounding safety and sterility issues and a newly posted document shows inspectors enforcing manufacturing standards.

Read More

October 28, 2024: DOJ hands down indictments and patients harmed by formulary change

October 28, 2024

Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.

Read More

A DSCSA-newbies guide to the recent FDA DSCSA announcement

October 22, 2024

The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.

Read More