Vivimed recalls hypertensive drug from US market due to impurities

 

HYDERABAD, May 7: Vivimed Life Sciences Pvt Ltd, a

city-based pharma company has started recalling 19 lots of

Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to

consumer level in US, as the product was found to have

impurities that may cause cancer, a US Food and Drug

Administration said.

The product is made by Vivimed at its Plant in Alathur,

Chennai and distributed by Heritage Pharmaceuticals Inc, East

Brunswick NJ in the US.

To date, neither Vivimed nor Heritage has received any

reports of adverse events related to this recall, it said.

“Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19

lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100

mg to consumer level due to detection of an impurity

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) that is above

the US Food and Drug Administration’s interim acceptable

exposure limit of 9.82 ppm.

Based on the available information, the risk of

developing cancer in a few patients following long-term use of

the product containing high levels of the impurity NMBA cannot

be ruled out,” the FDA said.

Losartan Potassium is indicated for the treatment of

hypertension, hypertensive patients with left ventricular

hypertrophy, nephropathy in Type 2 diabetic patients and is

packaged in 90-count and 1000-count bottles.

Torrent Pharmaceuticals Ltd also started recalling

certain batches of Losartan Potassium Tablets USP and Losartan

Potassium/hydrochlorothiazide tablets, USP, to the consumer

level due to the detection of trace amounts of an unexpected

impurity found in an active pharmaceutical ingredient (API)

manufactured by Hyderabad-based Hetero Labs Ltd. (PTI)