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FDA Alert: Dietary Supplement Recalled Due to Presence of Sildenafil and Diclofenac
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.
[...]FDA Alert: Dietary Supplement Contains Drug That Can Cause Heart Attack, Stroke and Internal Bleeding
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.
[...]November 11, 2024: Feds pursue companies selling fentanyl precursors
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.
[...]Indictment, USA v Hubei Aoks Bio-Tech Co and Xuening Gao et al
United States District Court Central District of Calfornia USA v Hubei Aoks Bio-Tech Co and Xuening Gao et al Indictment Filed May 10, 2024 Read the document.
[...]FDA Alert: Compounding Pharmacy in California Warned After Particulates Found in Injections
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.
[...]FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients
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.
[...]Indictment,USA v Wuhan Jinshang Import & Export Trading Company and Wenying Nie
United States District Court Middle District of Florida USA v Wuhan Jinshang Import & Export Trading Company and Wenying Nie Indictment Filed November 30, 2023 Read the document.
[...]Indictment, USA v Tianjin Furuntongda Tech Co and Wenxing Gao
United States District Court Middle District of Florida USA v Tianjin Furuntongda Tech Co, LTD and Wenxing Gao Indictment Filed January 4, 2024 Read the document.
[...]Indictment, USA v Hubei Shanglin Trading and Zhihan Wang
United States District Court Middle District of Florida USA v Hubei Shanglin Trading Company and Zhihan Wang Indictment Filed January 4, 2024 Read the document.
[...]Prescription Drug Affordability Board Activity through October 18, 2024
Colorado’s board reviewed proposed changes to PDAB legislation based on stakeholder testimony and board review and learned about Medicare’s Maximum Fair Price (MFP) determination. Over two meetings, Oregon’s board reviewed a draft constituent group engagement report and a UPL model that analyzed potential 2023 savings based upon MFP provided by their consultants and aggregate data collected from PBMs. The board also discussed ; policy recommendations from staff and a UPL draft report required by Senate Bill 192.
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