Cardinal Health Recalls Dexamethasone Sodium Phosphate Eye Drops
Cardinal Health Inc. is recalling 318 droptainers of Dexamethasone Sodium Phosphate 0.1% eye drops due 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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a theoretical risk from storage conditions rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Cardinal Health Inc. is recalling 318 droptainers of Dexamethasone Sodium Phosphate 0.1% 5ML eye drops. The recall is identified by recall number D-0447-2021 and involves product with code 353351. The affected units were distributed in Florida, Georgia, and South Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The source text does not specify a return address or refund process.
The recalled product
- Product
- DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 318
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)
- 353351
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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