PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 30, 2015 Initiated: August 24, 2015 #D-1818-2015

Product Description

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.

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.

Details

Recalling Firm
Allergan Sales, LLC
Units Affected
1,154,359 tubes
Distribution
Nationwide, Puerto Rico, and Barbados
Location
Waco, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Allergan Sales, LLC. Units affected: 1,154,359 tubes.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 30, 2015. Severity: Moderate. Recall number: D-1818-2015.