Losartan Recall Expanded Over Carcinogen Presence

Losartan Recall Expanded Over Carcinogen Presence

Introduction

After detecting the third cancer-causing impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), the FDA and Torrent Pharmaceuticals have expanded the nationwide recall for generic losartan pills on April 18, 2019.

The company expanded its recall for 36 lots of Losartan Potassium Tablets USP and 68 lots of Losartan Potassium/hydrochlorothiazide tablets, to the consumer level as trace amounts of unforeseen impurity was detected in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. This recall applies only to those lots which have NMBA levels above the current acceptable daily intake levels. Torrent indicated that it had notified the distributors and customers over the phone as well as through a written letter requesting them to discontinue selling or using the recalled lots. Arrangements have been made by the company to return all affected tablets to Qualanex for disposal. The first recall for generic blood pressure drugs, valsartan, was announced in July 2018, when it was found that the U.S. supply of the drug distributed for years was contaminated with carcinogenic chemicals.

Previous recalls were the result of the presence of   N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in the blood pressure medications, which are known to increase the chances of cancer in humans. The recalls impacted different generic version of valsartan, losartan, irbesartan, and other products.