Home / Recalls / Inventia Healthcare Private Limited / D-0224-2017

D-0224-2017 Class II Terminated

Recalled by Inventia Healthcare Private Limited — Thane, N/A

Recall Details

Product Type
Drugs
Report Date
December 28, 2016
Initiation Date
October 19, 2016
Termination Date
June 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,848 delayed-release capsules

Product Description

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 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 Pattern

United States

Code Information

Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17