Exact FDA event identifier

Event 87349

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

Event summary

Timeline bucket: February 22, 2021
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: SUN PHARMACEUTICAL INDUSTRIES INC

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96

D-0289-2021

Recall number: D-0289-2021
Initiated: February 22, 2021
Classification: Class III
Status: Terminated
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Quantity: 37,400 cartons/60 vials per carton

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent

Code information

Lot 10007, exp. date 01/2022

Distribution pattern

Nationwide and Australia