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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75092

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 02, 2016
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
United Exchange Corporation

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

4 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 4

EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

D-0496-2017
Recall number
D-0496-2017
Initiated
September 02, 2016
Classification
Class I
Status
Terminated
Quantity
46,080 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

Code information

Lot # G15905, G15907, Exp 10/2018

Distribution pattern

Nationwide, Puerto Rico and Guyana

drug · product 2 of 4

Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97

D-0497-2017
Recall number
D-0497-2017
Initiated
September 02, 2016
Classification
Class II
Status
Terminated
Quantity
112,320 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lot # G15908, Exp 10/2018; G15909, Exp 01/2018; G16904, Exp 01/2019; G16908, Exp 02/2019; G16912, G16913, Exp 03/2019

Distribution pattern

Nationwide, Puerto Rico and Guyana

drug · product 3 of 4

Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828

D-0498-2017
Recall number
D-0498-2017
Initiated
September 02, 2016
Classification
Class II
Status
Terminated
Quantity
77,184 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lot # G15901, G15902, G15903, G15904, Exp 07/31/2018; G16909, Exp 05/30/2019

Distribution pattern

Nationwide, Puerto Rico and Guyana

drug · product 4 of 4

EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

D-0499-2017
Recall number
D-0499-2017
Initiated
September 02, 2016
Classification
Class II
Status
Terminated
Quantity
190,710 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lot # G15906, Exp 10/2018; G15910, G15911, G15912, Exp 11/2018; G16901, G16902, G16903, Exp 01/2019; G16905, G16906, G16907, Exp 02/2019; G16910, G16911, Exp 03/2019

Distribution pattern

Nationwide, Puerto Rico and Guyana