Posts Tagged ‘FDA Alert’
FDA Alert: Suprimo Imports Warned by FDA After Reports of Illness and Death Due to Prescription Drug Ingredients in Their Dietary Supplements.
“On April 20, 2022, FDA warned consumers not to purchase or use “Artri Ajo King” as FDA has received adverse event reports, including of liver toxicity and death, associated with the use of “Artri Ajo King” and similarly named products. While the Agency has not sampled and tested this product from your inventory to date, be advised of our serious concern about the safety of these products and that it is your legal responsibility under federal law to ensure this product does not contain any undeclared and potentially harmful ingredients.”
[...]FDA Alert: Three Dietary Supplement Consumer Warnings, All Contain Prescription APIs
The FDA has issued consumer warnings on three different dietary supplement sold as herbal compounds intended to treat joint pain, rheumatoid arthritis, gout, and liver detoxification. Each product contains undeclared prescription drug ingredients.
[...]FDA Alert: Dietary Supplement Recalled Due to Presence of Prescription Drug Ingredients
FOR IMMEDIATE RELEASE – April 26, 2023– West Sacramento, CA, Gear Isle is voluntarily recalling the following products listed in the table below to the consumer level. FDA analysis has found the products to be tainted with prescription drug ingredients.
[...]FDA Alert: Dietary Supplement For Vision Care Recalled Due to Unapproved and Dangerous Ingredients
TruVision Health LLC is recalling the dietary supplement products listed below because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine).
[...]FDA Alert: Nano Silver Dietary Supplement Triggers Recall
This recall has been initiated because the Product is labeled as a dietary supplement that, in the opinion of the government, makes unsubstantiated health claims that the product will prevent, treat, or cure COVID-19.
[...]FDA Alert: Candy Company Recalls Dietary Supplement Containing Prescription Ingredient
Risk Statement: PrimeZen Black 6000 capsules containing sildenafil and tadalafil 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.
[...]FDA Class 1 Recall: Imported, Non-FDA Approved COVID-19 Tests
Use of these tests may cause serious adverse health consequences or death. There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples.
[...]FDA Alert: Class 1 Recall of Unauthorized COVID-19 Tests
North American Diagnostics is recalling these tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. North American Diagnostics did not provide the FDA with adequate validation data to show that the test’s performance is accurate. Use of these tests may cause serious adverse health consequences or death.
[...]FDA Alert: Dietary Supplement Sold on Amazon Recalled for Presence of Prescription Drug Ingredients
The product was distributed via the internet and fulfilled by Amazon nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
[...]FDA Alert: Dietary Supplement Marketed for Pain Relief Recalled Due to Presence of Diclofenac and Dexamethasone
Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses. Consumption of undeclared dexamethasone may lead to severe and serious adverse events such as adrenal suppression, a disorder in which the adrenal glands do not produce enough hormones, and adverse consequences can range from limited adverse consequences to death.
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