RecallFDA · Apr 10, 2017
Named company: Vertical Pharmaceuticals, Inc.
One (1) lot (21511158) of the OB Complete DHA is being recalled because the label claim for "Omega-3 Fatty Acids" does not match the actual formulation.
RecallFDA · Mar 30, 2017
Named company: Ton Shen Health Inc
Product potentially contaminated with lead.
Warning letterFDA · Mar 24, 2017
Named company: Sanapac Co., Inc.
Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21,…
RecallFDA · Mar 23, 2017
Named company: Armada Nutrition
A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished…
RecallFDA · Mar 23, 2017
Named company: Armada Nutrition
A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished…
Import alertFDA · Mar 21, 2017
Named company: NIKKO YAKUHIN KOGYO CO.,LTD.
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: NIKKO YAKUHIN KOGYO CO.,LTD. Date Published : 03/21/2017 2 Chome , Hara;…
Warning letterFDA · Mar 20, 2017
Named company: Vacunda & Design
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, Sinai Cannabis Oil, Sinai Soursop Oil, and…
Warning letterFDA · Mar 16, 2017
Named company: DSE Healthcare Solutions, LLC
Our inspection revealed significant violations of Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or…
RecallFDA · Mar 9, 2017
Named company: VivaCeuticals, Inc. dba Regeneca Worldwide
The firm is recalling all herbal and dietary supplements because they were not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements.
RecallFDA · Mar 9, 2017
Named company: VivaCeuticals, Inc. dba Regeneca Worldwide
The firm is recalling all herbal and dietary supplements because they were not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements.