FDA Drug recall D-0077-2018
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
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class III recall of Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03 by Allergan Sales, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0077-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-10-19 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Allergan Sales |
| Distribution | US |
Product
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
Reason
Failed Impurities/Degradation Specifications.
Identifiers
| ndc | 0023-9211-03 |
|---|---|
| ndc | 0023-9211-05 |
| ndc | 0023-9211-10 |
| ndc | 0023-9211-15 |
| code_info | Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-20…Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019; c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0077-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.