Product: Duloxetine Delayed-release Capsules USP 30 mg  30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Reason for recall: Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle    The Initial reports stated one or two capsules in a bottle count of 30s opening.  First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Recall initiated: 20161019
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated