Dr. Reddy’s Laboratories is recalling over 3.25 lakh cartons of Zenatane (isotretinoin) capsules, used for the treatment of severe acne, from the US market due to failed dissolution specifications. The drug is manufactured by pharma firm Cipla at its Pune facility for Dr Reddy’s Laboratories.
While 13,221 cartons of the capsules in 10 mg strength are being recalled by the company, it is removing 89,118 cartons in 20 mg strength and 2,23,650 cartons in 30 mg. The product in the three strengths is being recalled due to Failed Dissolution Specifications: out of specification results observed for low dissolution.
Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.
