FDA Drug recall D-0009-2016
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg f…
- FDA Drug
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg f… by Apotex, citing lack of Assurance of Sterility: Failed preservative effectiveness testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0009-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-25 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
Product
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Reason
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Identifiers
| code_info | Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016 |
|---|
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-0009-2016%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.