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Blood Pressure Drug Recalled
Lannett Company Inc. is recalling 25,680 bottles of triamterene and hydrochlorothiazide capsules because samples failed to meet impurity/degradation specifications during routine testing, according to the January 25, 2023, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed by the Lannett Company, Philadelphia, Pennsylvania, throughout the United States:
- triamterene and hydrochlorothiazide capsules (37.5 mg/25 mg), 100-count bottles (NDC 0527-1632-01) and 1000-count bottles (NDC 0527-1632-10), from lots 21000279A (Exp. 1/23) and 20256320A (Exp. 12/22); and
- triamterene and hydrochlorothiazide capsules (37.5 mg/25 mg), 1000-count bottles (NDC 0527-1632-10), from lots 20256318A (Exp. 12/22), 20256321A (Exp. 12/22), and 21000238A (Exp. 1/23).
Lannett Company voluntarily initiated the recall November 9, 2022. On January 16, 2023, the FDA designated the recall Class III. Per the recall classification, use of the affected capsules is not likely to cause harm.
Triamterene and hydrochlorothiazide capsules are available with a prescription for the treatment of hypertension and edema in certain patients.