Unichem Pharma USA Recalls Doxazosin and Bisoprolol Tablets in USA
Unichem Laboratories' US subsidiary is voluntarily recalling Doxazosin Tablets (4mg) for appearance defects and Bisoprolol Fumarate/Hydrochlorothiazide Tablets (2.5mg/6.25mg) for impurity specification issues. No adverse events have been reported to date. The company prioritizes patient safety and product quality.
While the recall is voluntary and no adverse events have been reported, product recalls can lead to regulatory scrutiny, potential financial costs, and a negative impact on brand perception in the market.
The recall of pharmaceutical products due to defects or impurity issues is a negative development for the company, potentially impacting its reputation and sales.
Unichem Laboratories Limited announced that its wholly-owned subsidiary, Unichem Pharmaceuticals (USA), Inc., has initiated a voluntary recall of two of its products distributed in the USA. The first product is Doxazosin Tablets, USP, 4 mg strength in 1000 count bottles, which are being recalled due to a product appearance defect, specifically incorrect debossing on some tablets.
The second product recalled is Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg /6.25 mg strength in 100 count bottles. This recall is due to the products not meeting the N-Nitroso Bisoprolol impurity specification limits.
Unichem Laboratories has stated that they have not received any reports of adverse events related to these recalls to date. The company emphasized its highest priority on ensuring patient safety and maintaining product quality throughout its manufacturing and supply chain processes.
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