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
Recall Number: D-0509-2017
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Terminated
Report Date: 20170308
Initiation Date: 20170215
Termination Date: 20181219
Reason for Recall
Failed dissolution specifications - low dissolution results at S3 stage.
Product Description
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