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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81512

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

Open FDA event record

Event summary

Timeline bucket
November 05, 2018
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Kadesh International

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

puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.

D-0250-2019
Recall number
D-0250-2019
Initiated
November 05, 2018
Classification
Class I
Status
Terminated
Recalling firm
Kadesh International
Quantity
18,521 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: Product manufactured under non-sterile production conditions.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: Product manufactured under non-sterile production conditions.

Code information

All lots, no expiration dates are on the bottles.

Distribution pattern

Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.