Lupin recalls over 51,000 bottles of antibiotic in the US
Lupin, an Indian multinational pharmaceutical giant, is recalling 51,006 bottles of Cefdinir for Oral Suspension (250mg/5mL) from the US market. This is due to a "defective container: lack of seal integrity," as stated by the US Food and Drug Administration (USFDA). This medication, used for treating various bacterial infections, was manufactured at Lupin's Mandideep-based plant and distributed in the US, by Baltimore-based Lupin Pharmaceuticals, Inc. The USFDA classifies this as a Class II recall.
Implications of a Class II recall
A Class II recall is started when the use of, or exposure to, a product may cause temporary/medically reversible adverse health consequences. The chances of serious adverse health consequences in such cases is considered remote. Lupin's recall is voluntary and nationwide in the US. The recall was initiated on May 8 this year.
India's role in global generic medicine supply
India, where Lupin is headquartered, is the world's largest supplier of generic medicines. The country manufactures around 60,000 different generic brands across 60 therapeutic categories, and contributes to around 20% of the global supply. These goods are then shipped to over 200 countries in the world, with Japan, Australia, Western Europe, and the US being the primary supply destinations.