Maharashtra FDA Issues Stop-Use Notice for Coldrif Syrup Batch SR-13 Over Toxic Adulteration Reports
Maharashtra FDA Issues Stop-Use Notice for Coldrif Syrup Batch SR-13 Over Toxic Adulteration Reports
Mumbai: The Food and Drugs Administration (FDA) Maharashtra has issued an urgent stop-use and recall notice for Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), Batch No. SR-13, following reports of child deaths in Madhya Pradesh and Rajasthan allegedly linked to the consumption of the contaminated product.
According to FDA officials, laboratory investigations have revealed the presence of Diethylene Glycol (DEG) — a toxic chemical that can cause severe poisoning and death — in the affected batch. The syrup was manufactured by Sresan Pharma, located in Sunguvarchathiram, Kancheepuram District, Tamil Nadu, with manufacturing date May 2025 and expiry date April 2027.
The FDA has directed all license holders, pharmacies, hospitals, and distributors to immediately stop sale, distribution, and use of Coldrif Syrup Batch SR-13. Anyone in possession of the product must report it to local Drugs Control Authorities without delay.
The public can also report directly to the Food and Drugs Administration, Maharashtra, via toll-free number 1800-222-365, email [email protected], or phone 9892832289.
The Maharashtra FDA is coordinating with the Drugs Control Administration (DCA) Tamil Nadu to trace the distribution of the affected batch and has instructed all Drugs Inspectors and Assistant Commissioners to alert retailers, wholesalers, and healthcare facilities to immediately freeze stocks of the product.
FDA Maharashtra Commissioner D. R. Gahane confirmed that all necessary preventive actions are being taken and urged the public to exercise caution to prevent any further health risks.
