Cardinal Health Recalls Eszopiclone Tablets Due to Temperature Excursions
Cardinal Health is recalling 29 bottles of Eszopiclone 3mg tablets due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.
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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 29 bottles of Eszopiclone 3mg tablets (NDC 65862096901) due to Current Good Manufacturing Practice (CGMP) deviations. The recall is caused by intermittent exposure to temperature excursions during the storage of the product.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific code for the recalled items is GS0320010-A.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 29
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)
- GS0320010-A
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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