Cardinal Health Recalls Eletriptan Hydrobromide Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling Eletriptan Hydrobromide 20 mg tablets 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, and the hazard involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling Eletriptan Hydrobromide Tablets, 20 mg, distributed by Aurobindo Pharma USA, Inc. The recall is being conducted due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 59651-104-69 and lot code EA2020001-A. The recall involves 20 cartons of the medication. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- ELETRIPTAN HYDROBROMIDE (ELETRIPTAN HYDROBROMIDE)
- Brand
- ELETRIPTAN HYDROBROMIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 20
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)
- EA2020001-A
UPCs (1)
- 0359651105696
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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