Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
FDA's latest recalls records update includes Basic Reset CBD supplements and another 4,300 units of Tween Brands cosmetics containing colors made from banned dye. Recalls resulting from testing of ranitidine drugs reported by Dr. Reddy's.
Warning links retailers to multiple manufacturers inspected after FDASIA in 2012 pointed FDA toward inspecting all ex-US firms supplying products available in US but that had yet to be inspected for compliance. Manufacturers also were placed on import alerts to prevent their products, including cosmetics as well as drugs, from reaching US.
MSM Nutraceuticals may opt to use contract manufactures to resume marketing MSM-containing products. When it does, the firm is warned not to label and market its “MSM Pain Gel" and "MSM Nasal Spray" products as drugs.
Maker of single-dose topical swabs indicated for application to sores and open wounds asked o respond with information including a "thorough remediation plan to install and operate a suitable water system." FDA inspectors determined Swabplus didn't correct problem found in a 2016 inspection of failing to test incoming components.