Cardinal Health Recalls Edarbyclor Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 244 bottles of Edarbyclor tablets due to intermittent 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 due to CGMP deviations (temperature excursions) which are considered low-risk contamination or minor labeling/packaging issues without reported illness.
Plain-English summary
Cardinal Health Inc. is recalling 244 bottles of Edarbyclor (azilsartan kamedoxomil and chlorthalidone) tablets. The product is a prescription medication manufactured for Arbor Pharmaceuticals, LLC. The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP), specifically 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 78520. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE)
- Brand
- EDARBYCLOR
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 244
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)
- 78520
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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