Cardinal Health Recalls Tobramycin/Dexamethasone Eye Drops for Temperature Excursions
Cardinal Health Inc. is recalling 47 droptainers of Tobramycin/Dexamethasone eye drops due to intermittent temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 that might cause temporary or medically reversible adverse health consequences. The hazard is a storage temperature excursion, which is a quality control issue rather than a direct contamination or structural defect.
Plain-English summary
Cardinal Health Inc. is recalling 47 droptainers of Tobramycin/Dexamethasone 0.3-0.1% 10ml ophthalmic drops (NDC 24208029510). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled units is 350861.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 47
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)
- 350861
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.
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