RecallFDA · Sep 9, 2021
Named company: BRAINMD
It was discovered that bottles of Brain and Memory Power Boost was filled with multi vitamin-mineral product - NeuroVite Plus
RecallFDA · Sep 7, 2021
Named company: Baker's Corner Bakery
Butter and buttermilk declared in the ingredients statement but the Contains statement does not declare milk.
Warning letterFDA · Sep 7, 2021
Named company: Lysulin, Inc.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your “Lysulin ® Weight Loss Shake,” “Lysulin…
Warning letterFDA · Sep 7, 2021
Named company: Aceva, LLC
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your Sugar Balance product fails to bear…
Warning letterFDA · Sep 7, 2021
Named company: Ar-Rahman Pharm LLC
the Food and Drug Administration (FDA) reviewed your website at [see original source] in August 2021 and has determined that you take orders there for your Diabetes Support product. In addition, FDA reviewed…
Warning letterFDA · Sep 7, 2021
Named company: Radhanite, LLC d/b/a Curalife Ltd
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, CuraLin, fails to bear adequate directions for…
Warning letterFDA · Sep 7, 2021
Named company: McDaniel Water, LLC
Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.mcdanielwater.com and has observed that you take orders there for the product “Black Indian…
Warning letterFDA · Sep 7, 2021
Named company: Pharmaganics LLC
Curcumin treatment appeared to support healthy function of β-cells, the insulin producing cells of the pancreas.” • “Magnesium [ingredient in product]...Research shows that a 100 mg/day increase in magnesium…
Warning letterFDA · Sep 7, 2021
Named company: Holistic Healer & Wellness Center, Inc.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Diabalance Diabetes Supplement fails to bear…
Warning letterFDA · Sep 7, 2021
Named company: Nuturna International LLC
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your “Diabetic Support Formula” product fails…