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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72016

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

Open FDA event record

Event summary

Timeline bucket
August 24, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Allergan Sales, LLC

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

Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612.

D-1817-2015
Recall number
D-1817-2015
Initiated
August 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Allergan Sales, LLC
Quantity
320,713 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Code information

Lot #: a) 84746, Exp 04/17; 84987, 85087, Exp 05/17; 85359, Exp 06/17; 85721, Exp 07/17; 86045, Exp 08/17; 86406, Exp 09/17; 86594, Exp 10/17; 87021, Exp 11/17; and b) 86470, Exp 09/17; 86829, Exp 10/17; 87105, Exp 11/17

Distribution pattern

Nationwide, Puerto Rico, and Barbados

drug · product 2 of 4

Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3.

D-1818-2015
Recall number
D-1818-2015
Initiated
August 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Allergan Sales, LLC
Quantity
1,154,359 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Code information

Lot #: 85165, 85228, Exp 05/17; 85244, 85351, 85374, 85397, Exp 06/17; 85561, 85676, 85694, Exp 07/17; 85834, 85977, 85985, 86073, Exp 08/17; 85599, 86290, 86325, 86411, 86427, 86506, 86515, 86517, Exp 09/17; 86746, 86792, 86789, 86809, 86822, 86822A, Exp 10/17; 86932, 87100, 87068, Exp 11/17; 87156, 87261, Exp 12/17; 87493, Exp 01/18; 87494, 87731, Exp 02/18.

Distribution pattern

Nationwide, Puerto Rico, and Barbados

drug · product 3 of 4

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.

D-1819-2015
Recall number
D-1819-2015
Initiated
August 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Allergan Sales, LLC
Quantity
28,292 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Code information

Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17

Distribution pattern

Nationwide, Puerto Rico, and Barbados

drug · product 4 of 4

BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.

D-1820-2015
Recall number
D-1820-2015
Initiated
August 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Allergan Sales, LLC
Quantity
337 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Code information

Lot #: 86430, Exp 09/17; 87806, Exp 02/18; 88147, Exp 03/18

Distribution pattern

Nationwide, Puerto Rico, and Barbados