Product: Zenatane (isotretinoin) Capsules, USP, 10 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 55111-135-81
Reason for recall: Failed Dissolution Specifications: out of specification results observed for low dissolution.
Recall initiated: 20170522
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated