FDA recall D-1817-2015

Allergan Sales, LLC · Class II · 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.

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

Key facts

Status
Terminated
Initiation date
2015-08-24
Report date
2015-09-30
Termination date
2017-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waco, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1817-2015