Information
Glenmark Pharmaceuticals Inc. Recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0199-2026Drug / Pharmaceutical
Glenmark Pharmaceuticals Inc. Recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Glenmark Pharmaceuticals Inc., USA · Class III — Regulatory
Product Description
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Reason for Recall
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database