Hyderabad: Auromedics Pharma LLC,a US subsidiary of Aurobindo Pharma, has initiated voluntary recall of over 1.5 million bags of different anti biotic and anti-seizure injections from the US market due to “lack of assurance of sterility.”
According to a notification put up by the US Food and Drug Administration on its website, the recalls have been initiated by the firm under ‘Class-II’ classification.
The company started recalling nearly 0.4 million bags of Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, 0.67 million bags levo floxacin in 5 % Dextrose Injection of different strengths and0.52 million of Levetiracetam of different strengths, for the same reason, as per the notification.
Levetiracetam is used in combination with other medications to treat certain types of seizures in adults and children with epilepsy while Linezolidand Levofloxacinare used to treat infections.
“Lack of assurance of sterility’; confirmed customer report of a leaking bag and mold found between the outer bag and the overwrap,”the FDA said as reason for the recall.
According to the US health regulator, Class II recall is a situation in which 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.
The injections were manufactured by Aurobindo Pharma Limited at its Pashamylaram plant in Telangana for Auro Medics Pharma.
“Healthcare professionals patients and consumers who have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate,” FDA cautions in case of a recall.