CLASS II Drug recall · Reported 2 Jun 2021 · FDA Enforcement Report
Bromfenac Ophthalmic Solution recalled by Cardinal Health
Cardinal Health is recalling Bromfenac Ophthalmic Solution 09%, distributed in Florida, Georgia, South Carolina. The recall was initiated on 15 Mar 2021 and the FDA has classified it as Class II.
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-0413-2021
- FDA event ID
- 87512
- Recalling firm
- Cardinal Health, Dublin, OH
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2021
- FDA classified
- 24 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 15 Mar 2021 | Recall initiated by company | |
| 24 May 2021 | Classified by FDA | +70 days |
| 2 Jun 2021 | Published in enforcement report | +9 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: Intermittent exposure to temperature excursion during storage.
Product as listed by the FDA
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Where it was distributed
FL, GA, SC
Questions about this recall
Is Bromfenac Ophthalmic Solution 09% recalled?
Yes. Cardinal Health recalled Bromfenac Ophthalmic Solution 09% on 15 Mar 2021. The recall is Class II and its status is Terminated. Recall number D-0413-2021.
Why was it recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which lots are affected?
AGV009
Where was it sold?
FL, GA, SC
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Solution 0.09% recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Sterility | Nationwide |