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Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, ...

FDA Recall #D-0085-2024 — Class III — October 20, 2023

Recall #D-0085-2024 Date: October 20, 2023 Classification: Class III Status: Terminated

Product Description

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01

Reason for Recall

Failed Impurities/Degradation Specifications

Recalling Firm

Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

480 100-count bottles

Distribution

Nationwide in the USA

Code Information

Lot# 17212352, Exp 11/31/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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