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.

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Head of Missouri Pharmacy Association Calls for Rider-Free PDUFA Passage

One proposed amendment which could delay, or derail prompt passage, would allow importation of drugs from other countries which have not been inspected or approved by the FDA. Because the FDA ensures strict oversight of purity and effectiveness of the drugs in our supply chain, this proposal is dangerous. Everyday customs officials are finding counterfeit drugs which are laced with dangerous ingredients like fentanyl, mercury, lead, or other toxins.

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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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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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