Named company: EU Natural 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 “CONCEPTION Female Fertility Prenatal”…
Named company: Sal Nature LLC/FertilHerb
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, “FertilHerb for Women” fails to bear adequate…
Named company: NS Products, Inc.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following: On the home page: • “You avoid expensive surgical procedures, injections and…
Named company: Umbrella
As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 301(d)] and…
Named company: Garry N Sun USA Inc.
State of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg
Named company: Organic By Nature, Inc.
Product recalled due to undeclared milk in MCT powder used in manufacturing. Milk is not declared on the label. Product item #'s 4600-P65, 4600
Named company: Bio-Botanica, Inc.
Product contained cesium chloride, a New Dietary Ingredient
Named company: Hi Tech Pharmaceuticals
The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).
Named company: Hi-Tech Pharmaceuticals. Inc
Presence of 1,4-dimethylamylamine (DMAA)
Named company: Twenty-First Century Healthcare, Inc
A small quantity of bottles of Vitamin D3 125 mcg ((5000 IU) 100 ct. were mislabeled as Vitamin D3 25 mcg (1000 IU). Secondary labeling on the bottles (back label) is correctly labeled as Vitamin D3 125 mcg…
These results describe the included collection. Sources and coverage.