Named company: Hardcore Formulations
a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). In light of the fact that they are unapproved prescription drugs, the labeling of “Ultra-Sten” and…
Named company: Herbmed USA Company Inc.
Product contains undeclared milk.
Named company: Star Health & Beauty 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, your Nu Essentials Royal Jelly Capsules, NuMan…
Named company: Life Rising Corporation
During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements…
Named company: The Herbalist, Inc.
During the inspection, our investigators evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations and identified significant violations of the dietary supplement Current…
Named company: MusclMasster, LLC
MusclMasster, LLC is recalling all bottles of Al-Er-G Capsules because they contain the presence of Ephedra Herb, an FDA banned ingredient.
Named company: Genetic Edge Compounds LLC
Product contains DMAA and Methylsynephrine.
Named company: Bio TE Medical
The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements…
Named company: Nutri-Dyn Midwest, Inc.
During production of St. John's Wort, Lot 160876, a number of bottles were mistakenly labeled as Calcium D-Glucarate Plus
Named company: VitaPurity Corporation
We found serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations…
These results describe the included collection. Sources and coverage.