Lupin is recalling 43,860 bottles (3ml) due to failed impurities or degradation specifications, United States Food and Drug Administration (USFDA) said in an Enforcement Report.
Mumbai: Drug maker Lupin is recalling 43,860 bottles of Moxifloxacin Ophthalmic solution, used to treat bacterial conjunctivitis, in the US market. Bacterial conjunctivitis is one of the most commonly encountered eye problems in medicine. Most cases are acute, self-limited, and not a major cause of morbidity.
The Mumbai-based drug firm is recalling 43,860 bottles (3ml) due to failed impurities or degradation specifications, United States Food and Drug Administration (USFDA) said in an Enforcement Report.
The product is being recalled by Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of the company. The product has been manufactured at Lupin’s Pithampur-based manufacturing facility.
USFDA said, the product was distributed by five wholesalers, six drug chains, four mail order pharmacies and one mail order pharmacy or supermarket who may have further distributed it throughout the US.
The US health regulator has classified it as a class-III recall which is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a position in the Anti-TB segment.