FDA Drug recall D-1819-2015
FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04…
- FDA Drug
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04… by Allergan Sales, citing 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 fro….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1819-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-24 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Allergan Sales |
| Distribution | US |
Product
FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.
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.
Identifiers
| upc | 300230316040 |
|---|---|
| code_info | Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Allergan Sales
- Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only
FDA Device · Class II · 2024-05-08 · Allergan Sales - Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc
FDA Drug · Class II · 2019-04-03 · Allergan Sales - Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612
FDA Drug · Class III · 2017-11-22 · Allergan Sales - Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03
FDA Drug · Class III · 2017-11-22 · Allergan Sales - Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by…
FDA Drug · Class II · 2017-07-05 · Allergan Sales
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1819-2015%22
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