Notice: Torrent Pharmaceuticals Recalls Losartan Potassium/Losartan Potassium-HCTZ Tablets

Date: 10/04/19

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

On September 20, 2019, the U.S. Food and Drug Administration (FDA) announced that Torrent Pharmaceuticals Limited was recalling 5 additional lots of Losartan Potassium/Losartan Potassium-HCTZ Tablets to the consumer level due to the identification of an impurity, NMBA.

The FDA press release states the following:

Torrent Pharmaceuticals Limited is recalling 3 additional lots of Losartan Potassium tablets, USP and 2 additional lots of Losartan Potassium-Hydrochlorothiazide (HCTZ) tablets, USP 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. Losartan Potassium, USP, is a prescription medication commonly used to treat high blood pressure.

Please immediately check your medical supplies, quarantine any drug products impacted, and do not administer them. The identifying NDC and Lot numbers associated with Torrent’s recalled products are as follows: Losartan 50 mg tablets, (NDC 13668-409-10, Lot 4DU2E009), Losartan 100 mg tablets, (NDC 13668-115-90, Lot 4DU3E009), Losartan 100 mg tablets, (NDC 13668-115-10, Lot 4DU3E018), Losartan 50 mg/ Hydrochlorothiazide 12.5 mg tablets, (NDC 13668-116-90, Lot BEF7D051), Losartan 100 mg/ Hydrochlorothiazide 25 mg tablets, (NDC 13668-118-90, Lot 4P04D007).

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