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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79119

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

Open FDA event record

Event summary

Timeline bucket
February 02, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Aurobindo Pharma 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 Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.

D-0427-2018
Recall number
D-0427-2018
Initiated
February 02, 2018
Classification
Class III
Status
Terminated
Recalling firm
Aurobindo Pharma Ltd.
Quantity
7476 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: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

Code information

Lot#: MTSC17145-A, Exp. July 2021

Distribution pattern

Nationwide within the US