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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68348

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

Open FDA event record

Event summary

Timeline bucket
April 10, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bausch & Lomb, 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

2 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 2

Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637.

D-1410-2014
Recall number
D-1410-2014
Initiated
April 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb, Inc.
Quantity
a) 4,165 tubes; b) and c) 844,879 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Code information

Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16

Distribution pattern

Nationwide, Puerto Rico, Canada, and Hong Kong.

drug · product 2 of 2

Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.

D-1411-2014
Recall number
D-1411-2014
Initiated
April 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb, Inc.
Quantity
35,253 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Code information

Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15

Distribution pattern

Nationwide, Puerto Rico, Canada, and Hong Kong.