March 20, 2019
Macleods Pharma USA Inc. is recalling numerous lots of telmisartan and hydrochlorothiazide tablets because the tablets are out of specification for blend uniformity, according to the March 20, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed throughout the United States:
- telmisartan and hydrochlorothiazide tablets 40 mg/12.5 mg, 30-count bottles (NDC 33342-128-07), from lots BTL703A (Exp. 2/19); BTL705A (Exp. 4/19); BTL706A, BTL707A, and BTL708A (Exp. 5/19); BTL709A (Exp. 11/19); BTL710A, BTL711A, and BTL801A (Exp. 12/19); BTL802A and BTL803A (Exp. 2/20); BTL804A and BTL805A (Exp. 4/20); BTL807A and BTL807B (Exp. 5/20); BTL809A and BTL810A (Exp. 7/20); BTL811A (Exp. 9/20); and BTL812A and BTL813A (Exp. 10/20);
- telmisartan and hydrochlorothiazide tablets, 80 mg/12.5 mg, 30-count bottles (NDC 33342-129-07), from lots BTM703A, BTM704A, BTM706A, and BTM707A (Exp. 2/19); BTM708A and BTM709A (Exp. 4/19); BTM710A (Exp. 6/19); BTM711A and BTM712A (Exp. 10/19); BTM713A, BTM714A, and BTM715A (Exp. 11/19); BTM801A, BTM802A, BTM803A, and BTM804A (Exp. 12/19); BTM806A and BTM807A (Exp. 3/20); BTM809A (Exp. 4/20); BTM810A, BTM811A, and BTM812A (Exp. 7/20); BTM813A, BTM814A, BTM815A, BTM816A, and BTM817A (Exp. 9/20); and BTM818A and BTM819A (Exp. 11/20); and
- telmisartan and hydrochlorothiazide tablets, 80 mg/25 mg, 30-count bottles (NDC 33342-130-07), from lots BTN703A and BTN704A (Exp. 2/19); BTN705A and BTN706A (Exp. 5/19); BTN707A (Exp. 6/19); BTN810A (Exp. 6/20); BTN811A and BTN812A (Exp. 8/20); BTN813A and BTN814A (Exp. 9/20); BTN802A, BTN802B, BTN803A, and BTN804A (Exp. 12/19); BTN805A, BTN806A, BTN807A, and BTN807B (Exp. 2/20); BTN808A (Exp. 4/20); BTN809A and BTN810A (Exp. 6/20); BTN811A and BTN812A (Exp. 8/20); and BTN813A and BTN814A (Exp. 9/20).
Macleods Pharma USA voluntarily initiated the recalls February 25, 2019. On March 14, 2019, the FDA designated them 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.
Telmisartan and hydrochlorothiazide tablets are available with a prescription for the treatment of high blood pressure.