Hypertension Products Recalled

Torrent Pharma Inc. is recalling several losartan products because the carcinogenic substance N-nitrosodimethylamine (NDEA) was identified in an active pharmaceutical ingredient used to manufacture the drug. The recalls were included in the February 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recalls affect the following products, which were distributed throughout the United States and in Puerto Rico:

• losartan potassium tablets, 25 mg, in 90-count bottles (NDC 13668-113-90) from lot 4O49C013 (Exp. 9/19);  
• losartan potassium tablets, 50 mg, in 30-count bottles (NDC 13668-409-30) from lot 4L67C035 (Exp. 10/19); in 90-count bottles (NDC 13668-409-90) from lot 4L67C035 and 4L67C036 (Exp. 10/19); and in 1000-count bottles (NDC 13668-409-10) from lot 4O50C005 (Exp. 11/19);
•  losartan potassium tablets, 100 mg, in 30-count bottles (NDC 13668-115-30) from lot BO31C016 (Exp. 4/19); in 90-count bottles (NDC 13668-115-90) from lot BO31C016 (Exp. 4/19); and in 1000-count bottles (NDC 13668-115-10) from lots 4DK3C004 and 4DK3C005 (Exp. 4/19), 4DU3C040 (Exp. 10/19), and lots 4DU3E049 and 4DU3E050 (Exp. 5/21); 
• losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, in 90-count bottles (NDC 13668-116-90) from lot BP02C008 (Exp. 3/19); and in 1000-count bottles (NDC 13668-116-10) from lot BEF7D006 (Exp. 3/20); and
•  losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, in 90-count bottles (NDC 13668-117-90) from lots BX35C020 (Exp. 5/19) and BX35C049 (Exp. 8/19); and in 1000-count bottles (NDC 13668-117-10) from lots BX35C022 and BX35C023 (Exp. 5/19).

Torrent Pharma voluntarily issued the recalls December 20, 2018. On February 15, 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 high blood pressure and to protect kidneys from diabetes-related damage.

—Jolynn Tumolo