D-1818-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 30, 2015
- Initiation Date
- August 24, 2015
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,154,359 tubes
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.
Distribution Pattern
Nationwide, Puerto Rico, and Barbados
Code Information
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.