CLASS II Drug recall · Reported 30 Sep 2015 · FDA Enforcement Report
Refresh P.M. (Mineral Oil recalled by Allergan Sales
Allergan Sales is recalling Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, distributed nationwide in the US. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1818-2015
- FDA event ID
- 72016
- Recalling firm
- Allergan Sales, Waco, TX
- Brand
- Refresh P.m
- Manufacturer
- Allergan, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2015
- FDA classified
- 22 Sep 2015
- Reported
- 30 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 24 Aug 2015 | Recall initiated by company | |
| 22 Sep 2015 | Classified by FDA | +29 days |
| 30 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide, Puerto Rico, and Barbados
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Nationwide, Puerto Rico, and Barbados
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 72016This product is part of a recall event; the main page for the event is Refresh Lacri-Lube (Mineral Oil recalled by Allergan Sales.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Refresh Lacri-Lube (Mineral Oil recalled by Allergan SalesRefresh Lacri-lube | Allergan Sales | Particulate Matter | Nationwide | |
| CLASS II | FML (fluorometholone ophthalmic ointment) 0.1% tube recalled | Allergan Sales | Particulate Matter | Nationwide | |
| CLASS II | Blephamide (sulfacetamide sodium recalled by Allergan Sales | Allergan Sales | Particulate Matter | Nationwide |
More recalls from Allergan Sales
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Keller Funnel recalled by Allergan Sales | Allergan Sales | Other | Nationwide |
| Drug | CLASS II | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Manufacturing (CGMP) Deviations | TN |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS III | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS II | Blephamide (sulfacetamide sodium recalled by Allergan Sales | Allergan Sales | Potency & Assay | Nationwide |
Other Mineral Oil recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment recalledGenteal | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | ActivEyes Sterile Altalube Ointment recalled by Altaire PharmaceuticalsAltalube | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Refresh Lacri-Lube (Mineral Oil recalled by Allergan SalesRefresh Lacri-lube | Allergan Sales | Particulate Matter | Nationwide |