FDA-Drug2015-09-30Class II
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.
Allergan Sales, LLC
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.
Sold states
Nationwide, Puerto Rico, and Barbados
Affected count
1,154,359 tubes
Manufactured in
8301 Mars Dr, N/A, Waco, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1818-2015Don't want to check this manually?
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