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 relieve mild to moderate pain and reduce fever.
USFDA noted that Lupin has initiated the recall of the affected lot due to,”Failed Impurities/Degradation Specifications”.
The product has been manufactured at Lupin’s Aurangabad (Maharashtra) based manufacturing plant.
The company initiated the recall, which the US health regulator has classified as Class III, on January 21 this year.
As per the USFDA, a class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.
AuroMedics Pharma is recalling affected lots of Acetaminophen injection which have been produced in India, USFDA said.
The company is recalling the lot due to “discoloration and failed pH specifications”, it added.
AuroMedics initiated the nationwide recall on December 30, 2020.
The USFDA has classified the initiative as a Class II recall, which is initiated in 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.