Drug recall D-1817-2015
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.
Lots and codes
Lot #: a) 84746, Exp 04/17; 84987, 85087, Exp 05/17; 85359, Exp 06/17; 85721, Exp 07/17; 86045, Exp 08/17; 86406, Exp 09/17; 86594, Exp 10/17; 87021, Exp 11/17; and b) 86470, Exp 09/17; 86829, Exp 10/17; 87105, Exp 11/17
Recall details
- Recalling firm
- Allergan Sales, LLC, Waco, TX
- Quantity
- 320,713 tubes
- Distribution
- Nationwide, Puerto Rico, and Barbados
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 24, 2015
- Terminated
- April 19, 2017
Related products
- Refresh Lacri-lube – drug information
- NDC 0023-0312 Refresh Lacri-lube · Mineral Oil 425 mg/g; Petrolatum 568 mg/g · Allergan, Inc.