RecallFDA · Nov 17, 2017
Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2, recall F-0396-2018
Named company: Pure Encapsulations, Inc.
Product contains undeclared sulfites.
Recalls & Safety Records
RecallFDA · Nov 17, 2017
pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7, recall F-0397-2018
Named company: Pure Encapsulations, Inc.
Product contains undeclared sulfites.
Warning letterFDA · Oct 31, 2017
Stanley Brothers Social Enterprises, LLC 10/31/17
Named company: Stanley Brothers Social Enterprises, LLC
For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex [ 1] Under FDA’s regulations [21 CFR § 312.2], unless a clinical…
Warning letterFDA · Oct 31, 2017
Green Roads of Florida LLC 10/31/17
Named company: Green Roads of Florida 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, “CBD Oil” (100mg, 250mg, 350mg, 550mg), “CBD…
Warning letterFDA · Oct 31, 2017
Natural Alchemist 10/31/17
Named company: Herbal Alchemist
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, “Herbal Alchemist CBD (Cannabidiol) Capsules”…
Warning letterFDA · Oct 31, 2017
That's Natural 10/31/17
Named company: That's Natural
Unapproved New Drugs and Misbranded Drugs Although you market “CBD All-Natural Hemp Oil” as a dietary supplement, FDA has concluded based on available evidence that CBD products are excluded from the dietary…
RecallFDA · Oct 19, 2017
bliss anti-stress formula Dietary Supplement, 60 Tablets, recall F-0681-2020
Named company: Market America Inc
Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy.
Recall noticeFDA · Oct 19, 2017
Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl Sibutramine
Named company: Kiriko, LLC
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market…
Warning letterFDA · Oct 6, 2017
Nexagen, LLC 10/6/17
Named company: Nexagen, LLC
Our inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111).…
Warning letterFDA · Sep 28, 2017
Total Body Nutrition 9/28/17
Named company: Total Body Nutrition
During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, and Holding Operations for Dietary…
These results describe the included collection. Sources and coverage.