Lupin recalling 16,272 bottles of Gatifloxacin Ophthalmic Solution in US market

08 Nov 2021 Evaluate

Lupin is recalling 16,272 bottles of Gatifloxacin Ophthalmic Solution, an antibiotic used to treat bacterial infections of the eyes, in US market. As per the US Food and Drug Administration (USFDA), the company's US-based unit is recalling the affected lot due to failed stability specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

The affected lot has been manufactured at Lupin's Pithampur-based plant in Madhya Pradesh. The lot has been distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc, the report stated. The drug maker initiated the nationwide (US and Puerto Rico) Class III voluntary recall on November 2 this year. As per USFDA, a Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. The US generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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