New Delhi : Sun Pharma and Cadila Healthcare are recalling one product each from the US market due to contamination and presence of “foreign” tablets respectively.
While Sun Pharmaceutical Industries Inc is recalling 83,188 single dose vials of Testosterone Cypionate injection, Zydus Pharmaceuticals USA Inc is recalling 9,561 bottles Atenolol tablets.
The injection is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Atenolol tablets are used for treatment of hypertension.
According to the latest Enforcement Report of the US health regulator, Sun Pharmaceutical Industries Inc is recalling 83,188 single dose vials of Testosterone Cypionate injection USP, 200 mg/mL, 1 mL vial manufactured by Sun Pharma Industries Ltd, India on account of “presence of particulate matter”.
As per the the United States Food and Drug Administration (USFDA) the nationwide ongoing voluntary recall by the firm is a class II recall.
On the other hand Zydus Pharmaceuticals USA Inc is recalling 9,561 bottles of Atenolol tablets, USP, 50 mg manufactured by Cadila Healthcare, India, the report said.
The reason for recall is presence of foreign tablets/ capsules – “customer complaint that a bottle of atenolol 50 mg tablets USP contained a paroxetine 20 mg tablet”, it added.
The firm initiated nationwide recall in the USA and Puerto Rico recall is also a class II recall, the report said.
As per the USFDA, 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”.