Cardinal Health Recalls Ezetimibe and Simvastatin Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling Ezetimibe and Simvastatin 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a storage deviation (temperature excursion) rather than a confirmed contamination or defect causing immediate severe harm.
Plain-English summary
Cardinal Health Inc. is recalling Ezetimibe and Simvastatin tablets (10-10mg, 30-count) due to Current Good Manufacturing Practice (CGMP) deviations. The specific issue identified is intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 68462-321-30 and code 17201603. The recall involves 7 cartons of the medication. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 7
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)
- 17201603
UPCs (3)
- 0368462321300
- 0368462322307
- 0368462323304
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.
See all 198 products in this recall →Related recalls
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