Lupin recalling 50,832 bottles of Gatifloxacin Ophthalmic Solution

17 Jan 2022 Evaluate

Lupin is recalling 50,832 bottles of Gatifloxacin Ophthalmic Solution, an antibiotic used to treat bacterial infections of the eyes. 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 company-initiated Class III voluntary recall in the US and Puerto Rico on December 22 last year.

Lupin is also recalling 23,965 bottles of Oxycodone Hydrochloride tablets, used for the treatment of moderate to severe pain. The company is recalling the lot due to out-of-specification impurity test result observed at 18-month long term stability time point. The company's US-based subsidiary initiated Class III recall on December 29 last year.

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

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