Pharma major 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 Testosterone Cypionate Injection is being recalled in the American market by the US arm of Sun Pharma, as per the latest enforcement report of the US Food and Drug Administration. The company started the nationwide recall on January 11, 2021.
As per the USFDA report, 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.
Explaining the reasons behind the Class III recall, the USFDA said: "Incorrect Labelling: Incorrect lot number on secondary packaging." 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".
In October last year, 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 Sun Pharma. The company has presence in the country since 1996 with a focus on generics, branded generics and over-the-counter (OTC) products.
With PTI inputs