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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81442

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

Open FDA event record

Event summary

Timeline bucket
October 24, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aurobindo Pharma Limited (Unit I)

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

Irbesartan Bulk Active Pharmaceutical Ingredient.

D-0127-2019
Recall number
D-0127-2019
Initiated
October 24, 2018
Classification
Class II
Status
Terminated
Quantity
1724.8 kgs.

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDEA (N-Nitrosodimethylamine), a carcinogen impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Code information

Manufacturing batch numbers: 1601100782, dispatch batch number 1601101589, exp. date 12/01/2018 1601100783, dispatch batch number 1601101590, exp. date 12/01/2018 1701111861, dispatch batch number 1701113404, exp. date 09/01/2020 1701112170, dispatch batch number 1701113405, exp. date 09/01/2020 1701112501, dispatch batch number 1701113406, exp. date 09/01/2020 1701112056, dispatch batch number 1701113407, exp. date 09/01/2020 1701112558, dispatch batch number 1701114283, exp. date 10/01/2020 1701112559, dispatch batch number 1701114285, exp. date 10/01/2020 1701112589, dispatch batch number 1701114286, exp. date 10/01/2020 1701113300, dispatch batch number 1701114289, exp. date 10/01/2020 1701113301, dispatch batch number 1701114291, exp. date 10/01/2020 1701113302, dispatch batch number 1701114708, exp. date 10/01/2020 1701113312, dispatch batch number 1701114709, exp. date 10/01/2020 1701115460, dispatch batch number 1701117039, exp. date 11/01/2020 1701115974, dispatch batch number 1701117040, exp. date 11/01/2020 1701115460, dispatch batch number 1701117041, exp. date 11/01/2020 1701115738, dispatch batch number 1701117042, exp. date 11/01/2020 1701115739, dispatch batch number 1701117043, exp. date 11/01/2020 1701115740, dispatch batch number 1701117044, exp. date 11/01/2020 1701115741, dispatch batch number 1701117045, exp. date 11/01/2020 1701115742, dispatch batch number 1701117046, exp. date 11/01/2020

Distribution pattern

Product was distributed to one customer in NY.