Named company: Confidence Inc./Confidence U.S.A. Inc.
Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C…
Named company: Mitra Distributing Inc.
Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat…
Named company: Chillin Mix Kratom
Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat…
Named company: Celletech, Ltd
Based on our review of your product labeling, including product labeling on your website which was most recently accessed in August 2018, as well as product labels collected during an inspection from January…
Named company: Church & Dwight Co
Product is misbranded. Bottles contain another product -GABA Calm Sublingual Orange tablets.
Named company: Healthy Healing dba Crystal Star
In addition, the Federal Trade Commission has reviewed your marketing claims for “Withdrawal Support” for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. A drug is…
Named company: Natures Bounty Inc
High level of microcystin observed in the product.
Named company: Hard Eight Nutrition LLC
FDA inspection found two lots of supplements that did not declare shellfish as an ingredient on the product label; shellfish is properly declared on website.
Named company: VIRTUS PHARMACEUTICALS LLC.
Virtus Pharmaceuticals, LLC has decided to initiate a recall of the following products : Virt-Nate Tablets and Virt Gard Tablets because product labels do not reflect the correct amount of Dietary Folate…
Named company: Zakah Life LLC
The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a…
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