Cardinal Health Recalls EDARBI Tablets Due to Temperature Excursions
Cardinal Health is recalling 328 bottles of EDARBI tablets 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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a storage deviation (temperature excursion) rather than a confirmed contamination or defect causing immediate harm.
Plain-English summary
Cardinal Health Inc. is recalling 328 bottles of EDARBI (azilsartan kamedoxomil) 80 mg tablets. The recall is due to current good manufacturing practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific code information for the recalled units is 78902-1.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- EDARBI (AZILSARTAN KAMEDOXOMIL)
- Brand
- EDARBI
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 328
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)
- 78902-1
UPCs (2)
- 0360631080308
- 0360631040302
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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