Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bot...

FDA Recall #D-0160-2023 — Class III — November 9, 2022

Recall #D-0160-2023 Date: November 9, 2022 Classification: Class III Status: Terminated

Product Description

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10

Reason for Recall

Failed Impurity/Degradation Specifications

Recalling Firm

Lannett Company Inc. — Seymour, IN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

5,640 bottles

Distribution

Nationwide USA

Code Information

Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023)

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated