Pharmaceuticals company Vivimed Life Sciences Pvt Ltd has decided to take back its Losartan Potassium Tablets USP 25mg, 50 mg and 100 mg. The Food and Drug Administration announced that the company would recall 19 lots of the tablet as they were detected with impurities that could cause cancer.
The production of the table takes place in Alathur, Chennai in a plant of Vivimed. After production, the tablet is dispatched to the US where Heritage Pharmaceuticals Inc. takes charge of the distribution in the country.
While the tablets are being retracted from the market, neither the producer nor the distributor has been notified regarding any mishap relating to the tablet’s recall.
The Food and Drug Administration said that the company has been asked to recall the tablet because it contains an excess of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The agency allows the acid to be up to a level of 9.82 ppm, the limit which Vivimed’s tablet exceeded.
The decision was taken after contemplating on the fact that the prolonged consumption of tablet may result in cancer in patients. The FDA said that the risk could not be ignored considering the disease was fatal.
Similar to the case with Vivimed, another pharmaceuticals company Torrent Pharmaceuticals Ltd is in the process of retracting some batches of Losartan Potassium Tablets. This recall was ordered as the tablets contained an impurity in API (active pharmaceutical ingredient). The API is produced by Hetero Labs Ltd, which is based in Hyderabad.
The tablet is generally prescribed to Type 2 diabetic patients for treating nephropathy. Besides that, the drug is also indicated to treat hypertension. It is generally sold in bottles containing 90 or 1000 tablets.