ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81

Recall Number: D-0098-2017

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class III

Status: Terminated

Report Date: 20161019

Initiation Date: 20160829

Termination Date: 20191108

Reason for Recall

Failed Dissolution Specifications

Product Description

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81