Recall of Teva Losartan Tablets Announced by FDA

Recall of Teva Losartan Tablets Announced by FDA

Introduction

The FDA has announced recall of Teva Losartan Tablets on April 27, 2019, due to the presence of cancer-causing Nitroso-N-methyl-4-aminobutyric acid (NMBA) in at least six lots of active pharmaceutical ingredient manufactured by Hetero Labs Limited in India.

NMBA  has been linked to reports of liver cancer, kidney cancer, gastric cancer and other injuries among users of blood pressure drugs. Similar recalls have been linked to the presence of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which have the same effect and has impacted generic versions of valsartan, losartan, irbesartan, and other products. The latest losartan recall only applies to the lots with a higher level of NMBA. This recall has affected six lots of Losartan Potassium Tablets, USP 25mg, which are light-green in color, film-coated and teardrop-shaped biconvex tablets. They are embossed with “LK 25” on one side and “>” on the other. This has also affected 29 lots of Losartan Potassium tablets USP 100 mg, which are dark green, film-coated, oval-shaped biconvex tablets which have “LK100” on one side and “>” on the other.

According to the recall, Teva has notified Golden State Medical Supply of Camarillo, California, the need for the recall, and the distributors and retailers are urged to stop selling the pills. A list of affected lots is available in the recall. Also, patients taking these are advised to continue taking them until they find an alternative tablet or treatment as discontinuing these pills would have a more adverse effect. The FDA has requested to report adverse events to MedWatch Adverse Event Reporting Program.