Import alertFDA · Oct 26, 2020
Named company: Daromale International Trading
"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: Daromale…
Warning letterFDA · Oct 23, 2020
Named company: Predator Nutrition
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are…
Warning letterFDA · Oct 23, 2020
Named company: Peterson Research Laboratories LLC
Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a…
RecallFDA · Oct 16, 2020
Named company: Starwest Botanicals, Inc
Direct customer tested product upon receipt and had a positive result for Salmonella.
Warning letterFDA · Oct 9, 2020
Named company: Prollergy Corporation/Ready Set Food
Based on our review, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs The claims on your company website, where products can be purchased, establish…
Warning letterFDA · Aug 25, 2020
Named company: Renewal Supplements 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, “Opi-Cure” fails to bear adequate directions…
Warning letterFDA · Aug 25, 2020
Named company: Nutritional Supplements Corporation Inc
In addition, this patented formula can help support the effectiveness of the antiviral and other drugs while its immune boosting nutrients help protect naturally from the toxic effects of the antiviral…
Import alertFDA · Aug 11, 2020
Named company: Farmakom Ltd
"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: Farmakom Ltd…
Import alertFDA · Jul 31, 2020
Named company: Prime Health Products
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: Prime Health Products Date Published : 07/31/2020 133 The West Mall Unit…
RecallFDA · Jul 24, 2020
Named company: Wellements LLC
Product contains undeclared milk