October 10, 2019
Torrent Pharma Inc. is recalling several losartan products after the detection of trace amounts of an unexpected impurity, according to the October 9, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“The impurity detected is N-Methylnitrosobutyric acid (NMBA),” stated a September 23, 2019, company announcement. “Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.”
The following losartan products, which were distributed throughout the United States and Puerto Rico, are included in the recall:
- losartan potassium tablets, 50 mg, 1000-count bottles (NDC 13668-409-10) from lot 4DU2E009 (Exp. 12/31/20);
- losartan potassium tablets, 100 mg, 90-count bottles (NDC 13668-115-90) from lot 4DU3E009 (Exp. 12/31/20);
- losartan potassium tablets, 100 mg, 1000-count bottles (NDC 13668-115-10) from lot 4DU3D018 (Exp. 2/28/21);
- losartan potassium/hydrochlorothiazide tablets, 50 mg/12.5 mg, 90-count bottles (NDC 13668-116-90) from lot BEF7D051 (Exp. 11/30/20); and
- losartan potassium/hydrochlorothiazide tablets, 100 mg/25 mg, 90-count bottles (NDC 13668-118-90) from lot 4P04D007 (Exp. 7/31/20).
Torrent Pharma voluntarily issued the recalls September 19, 2019. On October 2, 2019, the FDA designated them Class II, signaling use of the affected drugs may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.
Losartan is a prescription angiotensin receptor blocker used to treat hypertension and to protect kidneys from diabetes-related damage.