Drug product
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.
D-1818-2015
Product summary
- Event
- Event 72016
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,154,359 tubes
- Official record key
drug-enforcement:D-1818-2015
Official wording
Reason: 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.
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.
Distribution pattern: Nationwide, Puerto Rico, and Barbados
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter