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FDA (Drug enforcement)Recalled 2015-08-24closedclass ii

Allergan Sales, LLC: 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 0023-024

Is my product affected?

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.

  • Brand REFRESH P.M.

Check against the official notice below — it lists the full affected range.

What happened

Allergan Sales, LLC is recalling Refresh P.M. Lubricant Eye Ointment due to the presence of small black particles in the product. These particles come from the ointment tube cap and are generated when the cap is unscrewed from the aluminum tube, potentially introducing the particle into the product. The recall affects 1,154,359 tubes distributed nationwide, as well as in Puerto Rico and Barbados, across multiple lot numbers with expiration dates ranging from May 2017 through February 2018.

The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: Nationwide, Puerto Rico, and Barbados Quantity: 1,154,359 tubes Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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