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2024

Lupin, Eugia recall products from US over manufacturing issues: USFDA

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Drugmaker Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues, according to the US health regulator.

As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections.

Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications".

The affected lot has been produced at the company's Mandideep-based manufacturing plant in Madhya Pradesh.

The company commenced the Class II nationwide (US) recall on May 30 this year.

The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP.

The company is recalling the affected lot due to "failed impurities/degradation specifications", USFDA said.

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