Cardinal Health Recalls Ofloxacin Eye Drops Due to Temperature Excursions
Cardinal Health Inc. is recalling 339 bottles of Ofloxacin 0.3% 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, and the hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 339 bottles of Ofloxacin 0.3% 5ml ophthalmic drops (NDC 17478071310). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically 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 items is 427297.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 339
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)
- 427297
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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