Bromfenac Ophthalmic Solution 0 — Class III drug recall D-0487-2015
Terminated recall by Apotex Inc., reported 2015-04-22, distributed nationwide. CGMP Deviations: Product excipient was not re-tested at the appropriate date.
| Recall number | D-0487-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, N/A, Canada |
| Recall initiated | 2015-02-12 |
| Classified | 2015-04-15 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2016-12-30 |
| Distributed | Nationwide (US) |
| Quantity | 33,795 bottles |
| Reason classes | cgmp |
| NDC | 60505-0595-05, 60505-0595-06, 60505-0596-04 |
| Lot numbers | KY8496, KY8498, KZ2002, MC5426 |
| Expiration dates | 2016-01, 2016-02, 2016-04 |
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 for recall
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0487-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.