Cardinal Health Recalls Travoprost Ophthalmic Solution Due to Temperature Excursions
Cardinal Health Inc. is recalling 325 cartons of Travoprost Ophthalmic Solution 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 325 cartons of Travoprost Ophthalmic Solution, USP 0.004%, 2.5mL (NDC 60505-0593-4). The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product is a prescription ophthalmic solution distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled units is RW4409.
Consumers and healthcare providers should check their inventory for this specific lot code and NDC number. If the product is found, it should be quarantined and not used. For further information, contact Cardinal Health Inc. or the FDA.
The recalled product
- Product
- TRAVOPROST (TRAVOPROST)
- Brand
- TRAVOPROST
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 325
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)
- RW4409
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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