Posts by psm2016
FDA Alert: Dietary Supplement Recalled for Containing Prescription Drug Ingredients
This is a reprint of an FDA Alert.
[...]WHO Alert: Counterfeit Cancer Medicines Reported in Europe
Information provided to WHO by AstraZeneca, the genuine manufacturer of IMFINZI, has confirmed that the products identified in this Alert are falsified. Laboratory analysis of samples of the falsified IMFINZI have been carried out by AstraZeneca. The analysis confirmed that the vials of the falsified product contained no active pharmaceutical ingredient.
[...]FDA Alert: Recall Issued on “Herbal” Diet Pill Containing Prescription and OTC Drug Ingredients
FDA analysis has found these products to contain undeclared Furosemide, Dexamethasone and Chlorpheniramine. Furosemide was found at 5.24 mg/g or 1.84 mg/capsule. Dexamethasone was found at 2.22 mg/g or 0.780 mg/capsule. Chlorpheniramine was found at 4.38 mg/g or 1.54 mg/capsule.
[...]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.
[...]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.
[...]FDA Alert: Pain Relief-Marketed Dietary Supplement Recalled For Containing Prescription Steroids, Muscle Relaxants, and OTC Pain Relievers
Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.
[...]PSM Advocates for SHOP SAFE legislation at Anti-Counterfeiting Day on the Hill
Our Executive Director, Shabbir Safdar, along with PSM members, shared examples of pharmaceutical counterfeits and helped attendees understand why current systems for stopping counterfeit product sales do not work well.
[...]FDA Alert: Herbal Supplement Recalled for Containing Prescription Steroids and OTC Antihistamines
If used chronically at the recommended dose, dexamethasone could cause severe and serious adverse events such as adrenal suppression (a disorder in which the adrenal glands do not produce enough hormones), central nervous system and psychiatric/behavioral effects, weight gain, gastrointestinal effects, elevated blood glucose, increased infection risks, neuromuscular and skeletal side effects, ocular effects, cardiovascular effects, dermatologic effects endocrine and metabolic issues, among other adverse events not mentioned.
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