Recalls & Safety Records

Warning letterFDA · Mar 24, 2017

Sanapac Co., Inc. 3/24/17

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,…

Warning letterFDA · Mar 20, 2017

Vacunda & Design 3/20/17

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

DSE Healthcare Solutions, LLC

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

RegeneBlast, recall F-1824-2017

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

RegeneBoost, recall F-1823-2017

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.

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