Recall of Doxorubicin Hydrochloride 2mg/ml (20mg/10 Ml) pegylated liposomal concentrate for IV infusion (Caspria) with lot number JKN0969B by Merck Sharp and Dohme
The Philippine subsidiary of Merck Sharp and Dohme informed the FDA about the recall of Doxorubicin Hydrochloride 2mg/mL (20 mg/10mL) pegylated liposomal concentrate for IV infusion (Caspria) with lot number JKN0969B. The recall was being made due to cGMP non compliance by the manufacturer Sun Pharmaceutical Industry in Gujarat. The drug presented risk associated with safety and thus leading to major health consequences.FDA and other regulatory emphasize upon GMP which is a system of practices followed in the manufacture of food, drug and pharmaceutical product in order to have safe and quality product for public.
Doxorubicin Hydrochloride is an antitumor drug which in conjunction with other drugs is used in the treatment of tumors such as leukemia, lymphoma, sarcoma etc.