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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81343

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

Open FDA event record

Event summary

Timeline bucket
October 18, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
H J Harkins Company Inc dba Pharma Pac

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

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

D-0415-2019
Recall number
D-0415-2019
Initiated
October 18, 2018
Classification
Class II
Status
Terminated
Quantity
84, 5 ml bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

Code information

Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20

Distribution pattern

Nationwide in the USA and Puerto Rico