Dr. Reddy's Laboratories, Inc. recalls ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited,
Recalled October 19, 2016 · FDA recall D-0098-2017 · Dr. Reddy's Laboratories
Hazard
Failed Dissolution Specifications · FDA Class III
Units
3,858 prescription packs (115,680 capsules)
Sold at
nationwide
Description
Failed Dissolution Specifications
Product
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
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →