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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75642

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 19, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Inventia Healthcare Private Limited

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0224-2017
Initiated
October 19, 2016
Classification
Class II
Status
Terminated
Quantity
46,848 delayed-release capsules

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

United States