New Delhi: Sun Pharmaceutical Industries is recalling 36,275 cartons of a drug used to treat low testosterone levels in the US market for incorrect labelling. The US arm of the domestic pharma major is recalling Testosterone Cypionate Injection in the American market, according to the latest enforcement report of the US Food and Drug Administration.
The affected lot of the intramuscular injections was manufactured by the drug maker in India and distributed in the US by Princeton, New Jersey-based Sun Pharmaceutical Industries Inc, it said.
Elaborating on the reasons for the Class III recall, the USFDA said: “Incorrect Labelling: Incorrect lot number on secondary packaging.”
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”.
The company initiated the nationwide recall on January 11, 2021.
Last year in October, Sun Pharma had recalled 747 bottles of generic diabetes drug in the US due to the possibility of the affected lot containing cancer-causing nitrosodimethylamine above the acceptable intake limit.
The company had recalled RIOMET ER (metformin hydrochloride for extended-release oral suspension) due to deviation from the current good manufacturing practices — detection of N-nitrosodimethylamine impurity in finished drug product.
The US, the world’s largest pharmaceuticals market, is also the biggest market for Mumbai-based Sun Pharma. The company has presence in the country since 1996 with a focus on generics, branded generics and over-the-counter (OTC) products.