Dr. Reddy’s recalls 9,330 bottles of Sirolimus tablets in US due to impurities

14 Jul 2016 Evaluate

Dr. Reddy’s Laboratories is recalling 9,330 bottles of Sirolimus tablets in the US due to presence of impurities. The tablets were manufactured by pharma major at its Visakhapatnam plant. Sirolimus tablets are indicated for the prevention of organ rejection in patients aged 13 years or older receiving renal transplants.

According to United States Food and Drug Administration (USFDA), the pharma major’s US arm - Dr. Reddy’s Laboratories Inc is recalling 9,330 bottles of Sirolimus tablets, 1 mg on account of failed impurities. The reason for recall is ‘failed impurities/degradation: out of specification result for impurity secorapamycin’.

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas.


 

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