The botched batch includes more than 1 lakh telmisartan pills to treat hypertension and around 25,000 analgesic tablets. Nagpur: The Food and Drug Administration (FDA) has directed Government Medical College and Hospital (GMCH) and Indira Gandhi Government Medical College and Hospital (Mayo) to immediately stop distribution and recall certain medicines after samples of paracetamol 500mg, and telmisartan 40mg failed quality tests.
They collected samples from Mayo Hospital in August, and the September 10 test report found the drugs did not conform to prescribed quality standards, said top sources. The hospital had 25,000 paracetamol tablets, supplied in July, and recalled the stock, they said. More than 1,00,000 Parasev 500 tablets had also been procured by GMCH and Mayo Hospital.
Both medicines were manufactured by Indore-based Cureza Healthcare Private Ltd, FDA officials said. GMCH officials said the hospital acted immediately after receiving the letter. Following the test report, GMCH’s pharmacology department issued instructions to wards and outpatient departments to stop distributing the affected tablets and return the stock.
FDA officials said an investigation was underway to trace how many tablets from the affected batches had been dispatched. telmisartan failed the dissolution test — a quality check that measures how quickly and how much of the drug is absorbed While paracetamol tablets had spots. Medicines from the same batches will be recalled with FDA examining the supply chain and compliance of the manufacturer.