Lupin, Eugia recall products from US market: USFDA
Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to «failed content uniformity specifications».
The affected lot has been produced at the company's Mandideep-based manufacturing plant in Madhya Pradesh.
The company commenced the Class II nationwide (US) recall on May 30 this year.
The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP.
The company is recalling the affected lot due to «failed impurities/degradation specifications», USFDA said.
Eugia commenced the nationwide Class II recall on May 23 this year.
According to 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.
Eugia is also recalling 15,500 single-dose vials of Eptifibatide injection from the US market, the American health regulator said.
The medication prevents blood from clotting during episodes of chest pain or a heart
