Drug recall D-1818-2015
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.
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.
Lots and codes
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.
Recall details
- Recalling firm
- Allergan Sales, LLC, Waco, TX
- Quantity
- 1,154,359 tubes
- Distribution
- Nationwide, Puerto Rico, and Barbados
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 24, 2015
- Terminated
- April 19, 2017
Related products
- Refresh P.m. – drug information
- NDC 0023-0240 Refresh P.m. · Mineral Oil 425 mg/g; Petrolatum 573 mg/g · Allergan, Inc.
- NDC 0023-0667 Refresh P.m. · Mineral Oil 425 mg/g; Petrolatum 573 mg/g · Allergan, Inc.