Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:
Recalled March 8, 2017 · FDA recall D-0509-2017 · Dr. Reddy's Laboratories
Hazard
Failed dissolution specifications - low dissolution results at S3 stage. · FDA Class III
Units
4404 cartons
Sold at
U.S. Nationwide
Description
Failed dissolution specifications - low dissolution results at S3 stage.
Product
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →