Cardinal Health Recalls Ciprodex Eye Drops Due to Temperature Excursions
Cardinal Health is recalling Ciprodex eye drops due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 341 cartons of CIPRODEX (Ciprofloxacin 0.3 and Dexamethasone 0.1%) 7.5ml eye drops. The recall is due to current good manufacturing practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected product is identified by NDC/UPC 0078-0799-75 and code 20F02UA.
The recalled product was distributed in Florida, Georgia, and South Carolina. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. No specific instructions for disposal or replacement are provided in the source text.
The recalled product
- Product
- CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 341
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)
- 20F02UA
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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