Notice: New Impurity Leads to Recall of 104 Lots of Losartan Potassium and Losartan Potassium-HCTZ Tablets

Date: 05/07/19

Notice: New Impurity Leads to Recall of 104 Lots of Losartan Potassium and Losartan Potassium-HCTZ Tablets

On April 18, 2019 the U.S. Food and Drug Administration (FDA) announced that Torrent Pharmaceuticals Limited was recalling 104 additional lots of Losartan Potassium tablets and Losartan Potassium-Hydrochlorothiazide (HCTZ) combination tablets to the consumer level due to the identification of a new impurity, NMBA.

The FDA press release states the following:

Torrent Pharmaceuticals, Inc. is recalling 36 lots of Losartan potassium tablets, USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP for a total of 104 affected lots to the consumer level. This recall was prompted due to the detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer). NMBA is a potential human carcinogen. To date, Torrent has not received any reports of adverse events related to this recall. Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 1000ct bottles. The identifying NDC #s associated with Torrent’s product are as follows: Losartan 25 mg 13668-0113-90, 13668-0113-10; :Losartan 50 mg 13668-0409-90, 13668-0409-10; Losartan 100 mg 13668-0115-90, 13668-0115-10; Losartan/HCTZ 50mg/12.5mg 13668-0116-30, 13668-0116-90, 13668-0116-10; Losartan/HCTZ 100mg/12.5mg 13668-0117-90, 13668-0117-10; Losartan/HCTZ 100mg/25mg 13668-0118-30; 13668-0118-90; and 13668-0118-10.

Providers can review the FDA’s full press release by visiting the FDA website.