Cardinal Health Recalls Ondansetron HCL 4mg Tablets Due to Temperature Excursions
Cardinal Health is recalling 1,935 bottles of Ondansetron HCL 4mg 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 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 1,935 bottles of Ondansetron HCL 4mg tablets (NDC 65862018730) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.
The affected product is identified by the code ON0420015-A. The distribution pattern indicates that the product was shipped to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,935
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)
- ON0420015-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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