East Windsor-based AuroMedics Pharma LLC, a unit of Hyderabad-based Aurobindo Pharma, is recalling 3,094 cartons of Acetaminophen injection.
The drug is used to alleviate gentle to average ache and scale back fever.
USFDA famous that Lupin has initiated the recall of the affected lot resulting from,”Failed Impurities/Degradation Specifications”.
The product has been manufactured at Lupin’s Aurangabad (Maharashtra) based mostly manufacturing plant.
The firm initiated the recall, which the US well being regulator has categorized as Class III, on January 21 this 12 months.
As per the USFDA, a category III recall is initiated in a “scenario in which use of, or publicity to, a violative product isn’t more likely to trigger antagonistic well being penalties”.
AuroMedics Pharma is recalling affected a number of Acetaminophen injection which have been produced in India, USFDA mentioned.
The firm is recalling the lot resulting from “discoloration and failed pH specs”, it added.
AuroMedics initiated the nationwide recall on December 30, 2020.
The USFDA has categorized the initiative as a Class II recall, which is initiated in a scenario in which use of, or publicity to, a violative product might trigger short-term or medically reversible antagonistic well being penalties or the place the likelihood of great antagonistic well being penalties is distant.