Champaklal Maganlal Homeo Pharmacy Private Limited

Warning LetterOpen

IndiaIssued May 18, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateMay 18, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Champaklal Maganlal Homeo Pharmacy Private Limited
Location: India
FEI Number: N/A
Country: India
Issue Date: May 18, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Champaklal Maganlal Homeo Pharmacy Private Limited and related importers were cited for manufacturing and distributing unapproved new drugs "Bebelyn Diarrhea" and "Bebelyn Colic" without FDA approval in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to conduct adequate identity testing of glycerin, a high-risk component used in drug manufacturing, creating significant contamination risks with toxic substances like diethylene glycol and ethylene glycol. These violations were particularly concerning because the products were formulated and labeled for use in infants and children as young as 3 months old, raising serious public health safety issues given the known lethal effects of glycerin contamination documented worldwide.

Champaklal Maganlal Homeo Pharmacy Private Limited FDA Warning Letter, May 18, 2023