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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81855

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2018
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Allergan, PLC.

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

OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07

D-0387-2019
Recall number
D-0387-2019
Initiated
December 20, 2018
Classification
Class II
Status
Completed
Recalling firm
Allergan, PLC.
Quantity
133,716 Cartons

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: A silicone particulate was noted in Ozurdex.

Code information

E78689, exp. date 06/21/2019 E78726, exp. date 06/29/2019 E78729, exp. date 07/01/2019 E78894, exp. date 08/09/2019 E79157, exp. date 09/05/2019 E79233, exp. date 09/15/2019 E79366, exp. date 10/06/2019 E79891, exp. date 12/07/2019 E80122, exp. date 01/18/2020 E80216, exp. date 02/06/2020 E81080, exp. date 05/09/2020 E81083, exp. date 05/22/2020 E81273, exp. date 05/31/2020 E81344, exp. date 06/21/2020 E82526, exp. date 12/11/2020 E82638, exp. date 12/20/2020 E82738, exp. date 01/18/2021 E82741, exp. date 01/23/2021 E82847, exp. date 01/29/2021 E82852, exp. date 02/01/2021 E83029, exp. date 02/26/2021 E83364, exp. date 04/18/2021

Distribution pattern

Product was distributed to various accounts throughout the United States including VA and Government Accounts