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Blood Pressure Tablets Recalled
Macleods Pharma USA Inc and Lupin Pharmaceuticals Inc are recalling numerous lots of losartan potassium tablets, and losartan potassium and hydrochlorothiazide tablets. According to the May 11, 2022, US Food and Drug Administration (FDA) Enforcement Report, the medications are being recalled because azide impurity levels are above acceptable limits.
The Macleods Pharma recall includes the following losartan products, which were distributed throughout the United States:
- losartan potassium tablets, 25 mg, 90-count bottles (NDC 33342-044-10) and 1000-count bottles (NDC 33342-044-44), from lots BLH2002A (Exp. 11/22), BLH2003B (Exp. 11/22), and BLH2004A (Exp. 11/22);
- losartan potassium tablets, 50 mg, 30-count bottles (NDC 33342-045-07), 90-count bottles (NDC 33342-045-10), and 1000-count bottles (NDC 33342-045-44), from lots BLI2002A (Exp. 11/22), BLI2004A (Exp. 11/22), and BLI2104B (Exp. 5/23);
- losartan potassium tablets, 100 mg, 30-count bottles (NDC 33342-046-07), 90-count bottles (NDC 33342-046-10), and 1000-count bottles (NDC 33342-046-44), from lots BLI2107B (Exp. 6/23), BLI2101A (Exp. 12/22), BLI2103A (Exp. 12/22), and BLI2105A (Exp. 5/23);
- losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 30-count bottles (NDC 33342-050-07), 90-count bottles (NDC 33342-050-10), and 1000-count bottles (NDC 33342-050-44), from lots BLK2107B (Exp. 5/23), BLK2101A (Exp. 1/25), BLK2102A (Exp. 2/25), BLK2103B (Exp. 2/23), BLK2103C (Exp. 2/23), and BLK2104A (Exp. 5/23);
- losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, 30-count bottles (NDC 33342-051-07), 90-count bottles (NDC 33342-051-10), and 1000-count bottles (NDC 33342-051-44), from lots BLL2107B (Exp. 5/23), BLL2101A (Exp. 1/25), BLL2102A (Exp. 2/25), BLL2103B (Exp. 2/23), and BLL2104A (Exp. 5/23); and
- losartan potassium and hydrochlorothiazide tablets, 100 mg/25 mg, 30-count bottles (NDC 33342-052-07), 90-count bottles (NDC 33342-052-10), and 1000-count bottles (NDC 33342-052-44), from lots BLM2106B (Exp. 5/23), BLM2101A (Exp. 1/25), BLM2102A (Exp. 2/23), BLM2106A (Exp. 5/23), BLM2103B (Exp. 2/23), BLM2104A (Exp. 5/23), and BLM2110A (Exp. 6/23).
The Lupin Pharmaceuticals recall includes the following losartan products, which were also distributed throughout the United States:
- losartan potassium tablets, 25 mg, 90-count bottles (NDC 68180-376-03) and 1000-count bottles (NDC 68180-376-09);
- losartan potassium tablets, 50 mg, 90-count bottles (NDC 68180-377-03) and 1000-count bottles (NDC 68180-377-09);
- losartan potassium tablets, 100 mg, 90-count bottles (NDC 68180-378-03) and 1000-count bottles (NDC 68180-378-09);
- losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 30-count bottles (NDC 68180-215-06) and 90-count bottles (NDC 68180-215-09);
- losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, 30-count bottles (NDC 68180-216-06) and 90-count bottles (NDC 68180-216-09); and
- losartan potassium and hydrochlorothiazide tablets, 100 mg/25 mg, 30-count bottles (NDC 68180-217-06) and 90-count bottles (NDC 68180-217-09).
Specific lots affected by the Lupin Pharmaceuticals recall are listed in this week’s FDA Enforcement Report.
The voluntary recalls were initiated on March 31, 2022, by Lupin Pharmaceuticals and April 15, 2022, by Macleods Pharma. The FDA designated them Class II on May 3, 2022. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Losartan is a prescription medication used to treat high blood pressure.
