CLASS III Drug recall · Reported 22 Apr 2015 · FDA Enforcement Report
Bromfenac Ophthalmic Solution recalled by Apotex
Apotex is recalling Bromfenac Ophthalmic Solution 09%, distributed nationwide in the US. The recall was initiated on 12 Feb 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0487-2015
- FDA event ID
- 70720
- Recalling firm
- Apotex, Toronto, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Feb 2015
- FDA classified
- 15 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 12 Feb 2015 | Recall initiated by company | |
| 15 Apr 2015 | Classified by FDA | +62 days |
| 22 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Is Bromfenac Ophthalmic Solution 09% recalled?
Yes. Apotex recalled Bromfenac Ophthalmic Solution 09% on 12 Feb 2015. The recall is Class III and its status is Terminated. Recall number D-0487-2015.
Why was it recalled?
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Which lots are affected?
a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Bromfenac ophthalmic recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution 09%, a) bottles recalled by Mayne Pharma U | Mayne Pharma U | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Apotex | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Bausch & Lomb | Bausch & Lomb | Sterility | Nationwide |