Notice: Official Public Record
Infant Acid Reflux Solutions LLC FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 05, 2018
MODERATE SEVERITY
Los Angeles District Office 2018
Disclaimer: This report is an analysis of a public FDA warning
letter. It is not medical advice. If you have consumed these products and feel
unwell, contact a healthcare professional immediately.
Executive Summary
The FDA issued a warning letter to Infant Acid Reflux Solutions LLC on February 05, 2018 citing regulatory violations. The letter was issued by Los Angeles District Office.
Regulatory Violations
Detailed Analysis
False Claims and Regulatory Violations
“Each packet, mixed with a PPI such as omeprazole or lansoprazole, can provide you with seven to thirty days of infant acid reflux treatment . . ..”
Potential Health Risks
Consumers should be aware of potential risks associated with products from Infant Acid Reflux Solutions LLC.
Regulatory Context
This warning letter is part of the FDA's enforcement of federal regulations.
Key Entities Identified
Infant Acid Reflux Solutions LLC FDA Warning Letter
Frequently Asked Questions
- What did the FDA find wrong with Infant Acid Reflux Solutions LLC?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Infant Acid Reflux Solutions LLC 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 Infant Acid Reflux Solutions LLC products?
- If you have used products from Infant Acid Reflux Solutions LLC 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 Medical Disclaimer: This report is an analysis of public FDA
warning letters. It is not medical advice. If you have consumed these products
and feel unwell, contact a healthcare professional immediately. You can report
adverse events to the
FDA MedWatch program.