Lupin’s U.S.-based arm -- Lupin Pharmaceuticals, Inc. is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to 'defective container: lack of seal integrity'. 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. 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.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
