IMPORTANT Losartan Potassium and Losartan Potassium-HCTZ Tablets RECALL NOTICE

Date: 03/15/19

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On March 1, 2019 the U.S. Food and Drug Administration (FDA) announced that Torrent Pharmaceuticals Limited was recalling 114 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 60 lots of Losartan potassium tablets, USP and 54 lots of Losartan potassium/hydrochlorothiazide tablets, USP for a total of 114 affected lots to the consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric 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 as are follows: Losartan 25 mg 13668-113-90, 13668-113-10 ; Losartan 50 mg 13668-409-30, 13668-409-90, 13668-409-10; and Losartan 100 mg 13668-115-90, 13668-115-10; Losartan/HCTZ 50mg/12.5mg 13668-116-30, 13668-116-90, 13668-116-10; Losartan/HCTZ 100mg/12.5mg 13668-117-30, 13368-117-90; Losartan/HCTZ 100mg/25mg 13668-118-30, 13668-118-90, and 13668-118-10.

Providers can review the FDA’s full press release here.