New Delhi: Drug firm Lupin is recalling over 51,000 bottles of a generic antibiotic medication in the U.S. market due to a “defective container”, according to the American health regulator.
The U.S.-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,” U.S. Food and Drug Administration (USFDA) said in its latest Enforcement Report.
Cefrine Oral Suspension is indicated for the treatment of a range of bacterial infections.
The affected lot has been manufactured at Lupin’s Mandideep-based plant and marketed in the U.S. by Baltimore-based Lupin Pharmaceuticals, Inc., it said. The drug maker initiated the Class II nationwide (U.S.) voluntary recall on May 8 this year.
As per the USFDA, a Class II recall is initiated in a situation in which 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 with around 20% share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the U.S. as the main destinations.
