Cardinal Health Recalls Tobrex Ointment Due to Temperature Excursions
Cardinal Health Inc. is recalling 28 tubes of Tobrex 0.3% Ophthalmic Ointment due to intermittent exposure to 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 28 tubes of Tobrex 0.3% 3.5GM Ophthalmic Ointment (NDC/UPC 65064435). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by the code 20B14E. The recall covers distribution in Florida, Georgia, and South Carolina.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 28
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)
- 20B14E
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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