FDA Drug recall D-0487-2015
Bromfenac Ophthalmic Solution 0.09%, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class III recall of Bromfenac Ophthalmic Solution 0.09%, Rx Only by Apotex, citing CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0487-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-12 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
Product
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
Reason
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Identifiers
| code_info | a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016. |
|---|
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-0487-2015%22
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