Drug firm Dr Reddy’s Laboratories Inc is recalling over 3.25 lakh cartons of Zenatane (isotretinoin) capsules, used for the treatment of severe acne the, 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 223,650 cartons in 30 mg, latest Enforcement Report of the USFDA said.
The product in the three strengths is being recalled due to “Failed Dissolution Specifications: out of specification results observed for low dissolution”, it added. The ongoing voluntary class II recall is nationwide in the USA and Puerto Rico, the United States Food and Drug Administration (USFDA) said. Zenatane is indicated for the treatment of severe recalcitrant nodular acne.
As per 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”.