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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78541

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

Open FDA event record

Event summary

Timeline bucket
November 09, 2017
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Kareway Products 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

GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04

D-0551-2018
Recall number
D-0551-2018
Initiated
November 09, 2017
Classification
Class I
Status
Terminated
Recalling firm
Kareway Products Inc
Quantity
60,000 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans

Code information

Lot #: 86041601, Exp 09/19

Distribution pattern

Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.