The Maharashtra Food and Drug Administration (FDA) has instructed two government hospitals in Nagpur to stop distributing and recall specific batches of paracetamol 500mg and telmisartan 40mg after samples failed prescribed quality tests.
The affected hospitals are Government Medical College and Hospital (GMCH) and Indira Gandhi Government Medical College and Hospital, commonly known as Mayo Hospital.
The medicines were manufactured by Indore-based Cureza Healthcare Private Ltd, according to FDA officials. The affected stock includes around 25,000 paracetamol tablets received by GMCH and more than 1 lakh telmisartan tablets procured by GMCH and Mayo Hospital.
Paracetamol and Telmisartan Batches Fail Quality Tests
FDA officials collected samples of the medicines from Mayo Hospital in August. The test report issued on September 10 found that both medicines failed to meet the required quality specifications.
The paracetamol tablets are sold under the brand name Parasev 500 and belong to batch PTTC-108. The report noted spots and a slight variation in the colour of the tablets, although the remaining stock was reported to be normal.
The second medicine, telmisartan 40mg, belongs to batch CHPLT 416. Telmisartan is prescribed for high blood pressure. This batch failed the dissolution test, which measures how quickly and to what extent a medicine dissolves and becomes available for absorption.
Hospitals Asked to Stop Distribution and Recall Stock
Following the FDA communication, GMCH officials said the hospital took steps to withdraw the affected medicines. The hospital had received around 25,000 paracetamol tablets in July and recalled the stock after receiving the alert.
More than 1 lakh Parasev 500 tablets had also been procured by GMCH and Mayo Hospital. The pharmacology department at GMCH instructed wards and outpatient departments to stop distributing the affected stock and return the tablets.
The FDA is also investigating the quantity of medicines from the affected batches that was supplied to the hospitals. Officials are examining the manufacturer’s supply chain and compliance as part of the inquiry.
FDA Issues Notice to Mayo Hospital
The FDA has issued a notice to the Mayo Hospital administration under the Drugs and Cosmetics Act. The notice seeks documents related to the purchase, sale and distribution of the medicines.
Manish Chaudhary, assistant commissioner with the Maharashtra FDA, said medicines supplied to government hospitals are routinely tested and that action was taken after the latest test reports identified the quality concerns.
According to the official, samples of paracetamol and telmisartan collected in August did not meet the specified quality requirements, following which hospitals were directed to stop distribution and recall the available stock.
Disclaimer
This article is based on information provided in the source report and statements attributed to Maharashtra FDA officials. It is intended for general informational purposes and should not be considered medical advice. Patients should not stop, change or replace prescribed medicines without consulting a qualified healthcare professional.