Recall Expanded For 5 Lots Of Losartan Drugs

Recall Expanded For 5 Lots Of Losartan Drugs

Introduction

On September 19, the U.S. Food & Drug Administration (FDA) expanded recall on three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets. The recall announced on Monday included losartan drugs sold by Torrent Pharmaceuticals.

The affected batches include:

13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count. Batch number: 4DU2E009. Expiration date: 12/31/2020.

13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count. Batch number: 4DU3E009. Expiration date: 12/31/2020.

13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count. Batch number: 4DU3E018. Expiration date: 02/28/2021.

13668-116-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count. Batch number: BEF7D051. Expiration date: 11/30/2020.

13668-118-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. Batch number: 4P04D007. Expiration date: 07/31/2020.

The recalled drugs belong to a class called angiotensin II receptor blockers (ARBs) and are used to treat heart failure and high blood pressure. The recalled lots contained nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels as determined by the FDA. Drugmakers around the world have recalled their losartan, valsartan, and irbesartan products due to the presence of NMBA and other cancer-causing chemicals in active pharmaceutical ingredients sourced from suppliers in China and India.

More than 130 valsartan lawsuits in connection with the recalls are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J. Lawsuits associated with the irbesartan or losartan recall are currently not included in the federal litigation. However, a request to expand the proceeding to include these claims were made by a group of plaintiffs.