The U.S. arm of the domestic drug major Sun Pharmaceutical Industries Ltd. is recalling over 5,200 units of testosterone cypionate injections from the American market.
Sun Pharmaceutical Industries Inc. is recalling 5,215 units of 10 mL vials 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,” according to an enforcement report by the U.S. Food and Drug Administration.
The injections were manufactured by Sun Pharmaceutical Industries at its Halol facility, it said.
The ongoing voluntary nationwide recall is a class II recall.
According to the U.S. FDA, a class II recall is 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.
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