More Firms Recall Blood Pressure Tablets

Three more firms have announced voluntary recalls of losartan products because of azido impurity levels that are above acceptable limits. Recalls from RemedyRepack Inc, Preferred Pharmaceuticals Inc, and Direct Rx are included in the June 1, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The RemedyRepack recall includes the following losartan products:

• losartan potassium and hydrochlorothiazide tablets, 50/12.5 mg, 90-count bottles (repackaged NDC 70518-3231-00, original NDC 33342-0050-10), from lots B1377711-100521 (Exp. 10/31/22) and B1412137-102621 (Exp. 10/31/22)—the tablets were distributed in Florida;
• losartan potassium and hydrochlorothiazide tablets, 100/12.5 mg, 90-count bottles (repackaged NDC 70518-2564-00, original NDC 68180-0216-09), from lots B1364261-092721 (Exp. 9/30/22), B1377667-100521 (Exp. 10/31/22), B1412576-102621 (Exp. 10/31/22), and B1436925-111321 (Exp. 11/30/22)—the tablets were distributed in Florida, South Carolina, and Virginia; and
• losartan potassium and hydrochlorothiazide tablets, 100/25 mg, 90-count bottles (repackaged NDC 70518-2578-00, original NDC 68180-0217-09), from lots B1329507-082921 (Exp. 8/31/22), B1348363-091421 (Exp. 9/30/22), B1387286-101021 (Exp. 10/31/22), B1390974-101221 (Exp. 10/31/22), and B1426010-110521 (Exp. 11/30/22)—the tablets were distributed in Florida, South Carolina, and Virginia.

The Preferred Pharmaceuticals recall includes the following losartan products, which were distributed in Florida and California:

• losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 30-count bottles (NDC 68788-7758-3), from lots K1721E (Exp. 4/30/23) and H3021Q (Exp. 2/28/23); and
• losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 90-count bottles (NDC 68788-7758-9), from lots K1721D (Exp. 4/30/23) and K1021E (Exp. 7/31/23).

The Direct Rx recall includes the following losartan products, which were packaged for Macleods Pharma USA Inc and distributed in Florida:

• losartan potassium and hydrochlorothiazide tablets, 50/12.5 mg, 90-count bottles (NDC 72189-297-90), from lots 19NO2108 (Exp. 1/31/25), 19NO2114 (Exp. 1/31/25), and 22NO2126 (Exp. 1/31/25);
• losartan potassium and hydrochlorothiazide tablets, 100/12.5 mg, 90-count bottles (NDC 72189-290-90), from lot 25OC2116 (Exp. 5/31/23); and
• losartan potassium and hydrochlorothiazide tablets, 100/25 mg, 90-count bottles (NDC 72189-289-90), from lots 08NO2102 (Exp. 1/31/25), 17NO2118 (Exp. 1/31/25), 18NO2123 (Exp. 1/31/25), 25OC2114 (Exp. 1/31/25), and 22NO2105 (Exp. 1/31/25).

The recalls were initiated during the first 2 weeks of May 2022. By May 24, 2022, the FDA had designated them Class II, communicating use of the affected tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Earlier this spring, losartan recalls due to azido impurity levels were initiated by Macleods Pharma USA Inc and Lupin Pharmaceuticals Inc and were included in the May 11, 2022, FDA Enforcement Report.

Losartan is a prescription medication used to treat high blood pressure.