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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FDA Alert: Pain Relief Dietary Supplements Recalled Due to Presence of Diclofenac

Risk Statement: 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, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

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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.”

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FDA Alert: Dietary Supplement Sold on Amazon Recalled for Presence of Prescription Drug Ingredients

Recalled dietary supplement sold on Amazon

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.

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Dietary Supplement Sold on Amazon Recalled for Containing Prescription Drug Ingredients

Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Hard Dawn Rise and Shine Capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

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