Cardinal Health Recalls Bromfenac Ophthalmic Solution Due to Storage Temperature Excursions
Cardinal Health Inc. is recalling Bromfenac Ophthalmic Solution 0.09% due to intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 152 cartons of Bromfenac Ophthalmic Solution 0.09% (NDC 62332-508-17) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.
The affected product is a prescription ophthalmic solution containing bromfenac sodium. The recall covers 152 cartons with lot code AGV009. The product was distributed to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
- Brand
- BROMFENAC OPHTHALMIC SOLUTION 0.09%
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 152
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- AGV009
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
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