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Recall Observatory FDA recall evidence

Drug product

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

August 24, 2015

Class II

Product summary

Firm
Allergan Sales, LLC
Event
Event 72016
Status
Terminated
Classification
Class II
Quantity
320,713 tubes
Official record key
drug-enforcement:D-1817-2015

Official wording

Reason: 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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter