Recalls / Class II
Class IID-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.
- Brand name
- Refresh P.m.
- Generic name
- Mineral Oil, Petrolatum
- Active ingredients
- Mineral Oil, Petrolatum
- Route
- Ophthalmic
- NDCs
- 0023-0240, 0023-0667
- FDA application
- M018
- Affected lot / code info
- 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.
Why it was recalled
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.
Recalling firm
- Firm
- Allergan Sales, LLC
- Manufacturer
- Allergan, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 8301 Mars Dr, N/A, Waco, Texas 76712-6578
Distribution
- Quantity
- 1,154,359 tubes
- Distribution pattern
- Nationwide, Puerto Rico, and Barbados
Timeline
- Recall initiated
- 2015-08-24
- FDA classified
- 2015-09-22
- Posted by FDA
- 2015-09-30
- Terminated
- 2017-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1818-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.