Rainbow Gold Products Inc FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 04, 2017
Executive Summary
The FDA issued a warning letter to Rainbow Gold Products Inc on May 04, 2017 citing regulatory violations. The letter was issued by New Orleans District Office.
Detailed Analysis
False Claims and Regulatory Violations
Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray System (containing: diclofenac sodium topical solution 1.5% w/w, sterile alcohol prep swabs, HDPE bottle 6oz., meter dose spray cap, sterile latex gloves, CSR wrap), (NDC 51021-278-01), labeled with statement of intended use: “Treatment of signs and symptoms of osteoarthritis of the knee(s)”
Potential Health Risks
Consumers should be aware of potential risks associated with products from Rainbow Gold Products Inc.
Regulatory Context
This warning letter is part of the FDA's enforcement of federal regulations.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Rainbow Gold Products Inc?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Rainbow Gold Products Inc products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used Rainbow Gold Products Inc products?
- If you have used products from Rainbow Gold Products Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter