Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By:
Recalled June 14, 2017 · FDA recall D-0884-2017 · Dr. Reddy's Laboratories
Hazard
Failed Dissolution Specifications: out of specification results observed for low dissolution. · FDA Class II
Units
89,118 cartons
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Product
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, 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 →