New Delhi: The US arm of Sun Pharmaceutical Industries Ltd has recalled more than 5,200 units of testosterone cypionate injections from the American market, the latest enforcement report of the United States Food and Drug Administration (US FDA) has said. Sun Pharmaceutical Industries Inc. is recalling 5,215 units of 10 ml vials of testosterone cypionate injections in the strength of 200 mg/ml, on account of “presence of particulate matter: organic and inorganic compounds detected in vials of product”, the report said.
The injections were manufactured by Sun Pharma at its Halol plant.
According to the USFDA report, the ongoing voluntary nationwide recall is a Class II recall, 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”.
The injections are indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
PTI contributed to this story.