The Maharashtra Food and Drug Administration (FDA) has ordered the recall of more than 1.25 lakh tablets from two government hospitals in Nagpur after samples of paracetamol 500 mg and telmisartan 40 mg failed prescribed quality tests.
The affected medicines were supplied to Government Medical College and Hospital (GMCH) and Indira Gandhi Government Medical College and Hospital, commonly known as Mayo Hospital.
Paracetamol Tablets Showed Colour Variation
The paracetamol tablets were marketed under the brand name Parasev 500 and belonged to batch PTTC-108.
FDA testing found that the tablets had spots and a slight variation in colour. The sample was therefore found not to conform to the required quality specifications.
More than 1 lakh Parasev 500 tablets had been procured by GMCH and Mayo Hospital. GMCH alone had around 25,000 tablets supplied in July, all of which were recalled after the hospital received the FDA communication.
The hospital’s pharmacology department instructed wards and outpatient departments to immediately stop distributing the affected tablets and return the available stock.
Telmisartan Failed Dissolution Test
The second medicine involved is telmisartan 40 mg, commonly prescribed to control high blood pressure.
The affected tablets belong to batch CHPLT 416, manufactured by Indore-based Cureza Healthcare Private Ltd.
Unlike the paracetamol tablets, the telmisartan batch failed the dissolution test. This test checks how quickly and how much of a medicine dissolves so that its active ingredient can become available for absorption.
The FDA has ordered the affected stock to be withdrawn while officials investigate the supply chain and determine how much of the batch had already been distributed.
Samples Collected During Routine Testing
FDA officials collected samples from Mayo Hospital in August, with the test report issued on September 10.
The department said medicines supplied to government hospitals undergo regular quality testing. Following the failed results, both hospitals were instructed to halt distribution and recall the available stock.
The FDA has also issued a notice to Mayo Hospital under the Drugs and Cosmetics Act, seeking documents related to the purchase, sale and distribution of the medicines.
Investigation Into Manufacturer and Supply Chain
The FDA is now examining the distribution records of the affected batches and checking the manufacturer’s compliance.
Officials are also attempting to establish how many tablets from the affected batches were dispatched and where they were supplied.
The recall is currently focused on the identified batches that failed quality specifications. There is no indication that all paracetamol or telmisartan medicines available in the market are affected.
Summary
The Maharashtra FDA has ordered the recall of more than 1.25 lakh paracetamol and telmisartan tablets from two Nagpur government hospitals after quality tests failed.
