Lupin recalls over 51000 bottles of generic antibiotic Cefdinir for Oral Suspension in US
Pharmaceutical company Lupin has declared the recall of more than 51,000 bottles of its generic antibiotic Cefdinir for Oral Suspension from the US market. This action stems from defective containers that lack proper seal integrity, prompting apprehensions regarding quality control protocols.
According to the US Food and Drug Administration (USFDA), the Baltimore-based arm of Lupin commenced the Class II recall for 51,006 bottles of the medication on May 8. A Class II recall typically occurs when there is a potential for temporary or medically reversible adverse health consequences.
According to PTI report, the affected batch was manufactured at Lupin's plant in Mandideep, India, a nation that supplies around 20% of the global demand for generic medicines. While the quality mishap impacts the drug firm's reputation, it underscores the ongoing need for stringent quality control in pharmaceutical manufacturing.
Previously, the Medical Dialogues team reported that Glenmark, Lupin, and Natco Pharma, key players in the generic drug industry, are recalling products in the American market due to manufacturing concerns.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
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