Blood Pressure Tablet Recall Grows

PD-Rx Pharmaceuticals Inc is recalling more than 3000 bottles of losartan potassium tablets because of azido impurity levels that are above acceptable limits, according to the July 6, 2022, US Food and Drug Administration (FDA) Enforcement Report. The recall follows similar losartan recalls in recent months from RemedyRepack Inc, Preferred Pharmaceuticals Inc, Direct Rx, Macleods Pharma USA Inc, and Lupin Pharmaceuticals Inc.

The PD-Rx Pharmaceuticals recall includes the following losartan potassium products, which were manufactured by Vivimed Life Sciences Private Limited, Tamil Nadu, India, packaged and marketed by PD-Rx Pharmaceuticals, Oklahoma City, OK, and distributed throughout the United States:

• losartan potassium tablets, 25 mg, in 90-count bottles (NDC 72789-163-90, UPC 3 72789 16390 1), from lots D21C18 (Exp. 9/30/22), E21A28 (Exp. 9/30/22), E21C04 (Exp. 9/30/22), E21D59 (Exp. 9/30/22), G21B65 (Exp. 9/30/22), H21A12 (Exp. 9/30/22), H21D42 (Exp. 9/30/22), K21D19 (Exp. 10/31/22), and A22A73 (Exp. 10/31/22);
• losartan potassium tablets, 50 mg, in 90-count bottles (NDC 72789-164-90, UPC 3 72789 16490 8), from lots D21D63 (Exp. 11/30/22), E21A73 (Exp. 11/30/22), E21D35 (Exp. 11/30/22), F21A28 (Exp. 11/30/22), F21D04 (Exp. 9/30/22), G21B03 (Exp. 11/30/22), G21E23 (Exp. 11/30/22), H21B46 (Exp. 11/30/22), H21D46 (Exp. 8/31/23), H21D46 (Exp. 8/31/23), I21B67 (Exp. 1/31/23), J21A26 (Exp. 1/31/23), and J21C44 (Exp. 1/31/23); and
• losartan potassium tablets, 100 mg, in 90-count bottles (NDC 72789-165-90, UPC 3 72789 16590 5), from lots G21C26 (Exp. 7/31/22), H21B96 (Exp. 7/31/22), I21B39 (Exp. 7/31/22), I21C44 (Exp. 7/31/22), D21F35 (Exp. 10/31/22), E21A66 (Exp. 10/31/22), E21C72 (Exp. 10/31/22), E21F01 (Exp. 10/31/22), F21C15 (Exp. 10/31/22), F21E19 (Exp. 10/31/22), G21B14 (Exp. 10/31/22), K21A61 (Exp. 11/30/22), and L21A45 (Exp. 11/30/22).

PD-Rx Pharmaceuticals voluntarily initiated the recall June 6, 2022. On June 27, 2022, the FDA designated it Class II. 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.