Class II
Terminated
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
- Recall Initiated
- October 19, 2016
- Posted
- December 28, 2016
- Recall Number
- D-0224-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46,848 delayed-release capsules
- Firm Location
- Thane, India
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 30s 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.
Distribution
United States
Lot / Code Info
Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17
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