Aurobindo Pharma recalls drugs in US over lack of assurance of sterility
This is a class II recall, which is somewhat serious in nature. Aurobindo Pharma has received USFDA form 483 on its injectable facility and the recalled drugs are injectables.
Aurobindo Pharma’s US subsidiary AuroMedics Pharma LLC has initiated a voluntary Class II recall for two injections, Linezolid and Levofloxacin. As per the US drug regulator, the drug recall has been due to lack of assurance of sterility. The USFDA website also cites that there were confirmed customer report of leaking bags and mold was found between the outer bag and the overwrap.
This is a Class II recall which 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.
AuroMedics is a generic injectables distribution company and a subsidiary of Aurobindo Pharma.
Aurobindo Pharma, in March 2018, received USFDA form 483 with nine observations for its injectable facility IV located in Pashamylaram, Hyderabad. Unit-IV manufactures generic sterile injectables i.e. lyophilized and powder injections, prefilled syringes as well as ophthalmic and parenterals. Aurobindo Pharma has said that none of the nine observations are related to data integrity.
The form 483 on this facility had cited that the plant had shortcoming in controlling the aseptic conditions. It was also found by USFDA that the plant was not free of insects and rodents.