Warning letterFDA · Feb 5, 2019
Named company: Gold Crown Natural Products
Melatonin supplements such as melatonin with valerian tablets prevent the death of neurons caused by beta proteins which is a toxic substance which accumulates in the brain of the patients with this disorder.…
Warning letterFDA · Feb 5, 2019
Named company: TEK Naturals
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include the following: On the “BURN4HER INGREDIENTS” page of your www.burn4her.com website:…
Warning letterFDA · Feb 5, 2019
Named company: John Gray's Mars Venus LLC
These three nutrients can … reduce the risk of Alzheimer’s by half. There are much better ways to avoid a heart attack, including fish oil…” Below this claim, there is a link that says, “CLICK HERE to learn…
Warning letterFDA · Feb 5, 2019
Named company: Emmbros Overseas Lifestyle PVT LTD.
The pre-clinical studies of the herb [guduchi] has shown diverse pharmacological activities such as… antiulcer … anti-inflammatory, hypoglycemic, anti-diabetic and anti-cancer activity. The reports have shown…
Warning letterFDA · Jan 30, 2019
Named company: Phi Sciences
Based on the inspectional findings, a review of the product labels collected during the inspection, and a review of your website at www.phisciences.com , we have identified serious violations of the Federal…
RecallFDA · Jan 22, 2019
Named company: Twenty-First Century Healthcare, Inc
21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
RecallFDA · Jan 22, 2019
Named company: Twenty-First Century Healthcare, Inc
21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
RecallFDA · Jan 17, 2019
Named company: ProThera, Inc. dba SFI USA
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Import alertFDA · Jan 16, 2019
Named company: GOKCE BITKISEL URUNLER-UFUK GOKCE
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT". Firm/address: GOKCE…
RecallFDA · Jan 11, 2019
Named company: Nutrafuels, Inc.
Recalling firm's consignee conducted third party micro testing showing microbial contamination in specific lots of the following products: CTFO Sleep Support Oral Spray (Aspergillus), CTFO Pain Relief Oral…