The FDA has instructed all licence holders, retailers, hospitals, and the public to immediately stop the sale, distribution, or use of this batch and to report its possession to local Drug Control Authorities without delay
An official looks at bottles of the ‘Coldrif’ cough syrup after a raid by the Drug and Pharmaceuticals Department officials at Kataria Pharmaceuticals. Pic/PTI
The Food and Drugs Administration (FDA) in Maharashtra on Sunday issued an urgent alert following reports of child deaths in Madhya Pradesh and Rajasthan allegedly linked to a contaminated batch of Coldrif Syrup.
According to an official notification, the syrup, manufactured by Sresan Pharma in Tamil Nadu, is suspected to have been adulterated with Diethylene Glycol (DEG), a toxic chemical reportedly known to cause serious harm or even death if consumed.
The batch in question is Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), Batch No. SR-13, with a manufacturing date of May 2025 and expiry date of April 2027, the FDA notification said.
It said that the FDA has instructed all licence holders, retailers, hospitals, and the public to immediately stop the sale, distribution, or use of this batch and to report its possession to local Drug Control Authorities without delay.
"The public may also contact FDA Maharashtra directly on toll-free number: 1800 222 365, email: jchq.fda-mah@nic.in and phone: 98928 32289," the notification said.
It further said that the Maharashtra FDA officials were working closely with the Drug Control Administration (DCA) in Tamil Nadu to trace the movement of the contaminated product in Maharashtra. All Drugs Inspectors and Assistant Commissioners have been directed to alert retailers, wholesalers, and hospitals to immediately freeze any stocks of this batch if found. All necessary measures are being taken to prevent further harm. The public has been urged to remain cautious and report any information related to the syrup.
Meanwhile, a government doctor has been arrested and an FIR registered against both him and the manufacturer of a cough syrup suspected to have caused the deaths of 14 children in Chhindwara district, allegedly due to acute kidney failure, reported the PTI.
The Madhya Pradesh government has banned the sale of Coldrif cough syrup, which has been linked to the deaths. Lab analysis confirmed that the syrup was adulterated with Diethylene Glycol (DEG), a highly toxic chemical.
A case has been filed at Parasia Police Station against both the pharmaceutical company and a government doctor who had been illegally practising at a private clinic and allegedly continued to prescribe the syrup for nearly a month, despite signs of adverse effects.
(with PTI inputs)
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