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Recall Observatory FDA recall evidence

Drug 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

D-0224-2017

October 19, 2016

Class II

Product summary

Firm
Inventia Healthcare Private Limited
Event
Event 75642
Status
Terminated
Classification
Class II
Quantity
46,848 delayed-release capsules
Official record key
drug-enforcement:D-0224-2017

Official wording

Reason: 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.

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

Distribution pattern: United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.