Sun Pharma recalls 36,275 cartons of testosterone injection in US for labelling error

08 Feb 2021 Evaluate

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 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. The company initiated the nationwide recall on January 11, 2021.

Last year in October, the company 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.

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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