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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74878

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

Open FDA event record

Event summary

Timeline bucket
August 16, 2016
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Sperian Eye & Face Protection, 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

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

Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818

D-0216-2017
Recall number
D-0216-2017
Initiated
August 16, 2016
Classification
Class I
Status
Terminated
Quantity
9,744 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non Sterility; contaminated with Klebsiella pneumoniae

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non Sterility; contaminated with Klebsiella pneumoniae

Code information

Lot number: F16091-61, exp 03/2019 Product Codes: 32-000455-0000-H5, 32-000455-0036, 32-000461-0036, 32-000462-0000-H5, 32-000462-0036

Distribution pattern

Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.