Drug recall D-1817-2015

Class II Terminated reported Sep 30, 2015

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.

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.

Lots and codes

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

Recall details

Recalling firm
Allergan Sales, LLC, Waco, TX
Quantity
320,713 tubes
Distribution
Nationwide, Puerto Rico, and Barbados
Type
Voluntary: Firm initiated
Recall initiated
August 24, 2015
Terminated
April 19, 2017

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