Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx On...

FDA Recall #D-0199-2024 — Class II — January 26, 2022

Recall #D-0199-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Recalling Firm

CARDINAL HEALTHCARE — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2 units

Distribution

Nationwide USA

Code Information

Batch 21000279A, 21000280A

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated