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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67433

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

Open FDA event record

Event summary

Timeline bucket
January 28, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Caraco Pharmaceutical Laboratories, Ltd.

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

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

D-1089-2014
Recall number
D-1089-2014
Initiated
January 28, 2014
Classification
Class II
Status
Terminated
Quantity
2528 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Tablet

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Code information

Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016

Distribution pattern

Nationwide