Recall Alert: Lupin’s Generic Antibiotic Pulled Due to Container Issue

Drug company Lupin is recalling over 51,000 bottles of a generic antibiotic medication in the US due to a “defective container,” as reported by the American health regulator. The US-based arm of the drug maker is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to “defective container: lack of seal integrity,” according to the US Food and Drug Administration (USFDA). Cefdinir Oral Suspension is used for treating a range of bacterial infections. The affected lot has been manufactured at Lupin’s plant in Mandideep and marketed in the US by Baltimore-based Lupin Pharmaceuticals, Inc. The recall was initiated by the drug maker as a Class II nationwide voluntary recall on May 8 this year. According to the USFDA, a Class II recall is initiated when the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. India is the largest supplier of generic medicines, manufacturing around 60,000 different generic brands across 60 therapeutic categories, accounting for about 20% of the global supply. These products are shipped to over 200 countries, with Japan, Australia, Western Europe, and the US as the main destinations.