Cardinal Health Recalls SYMPROIC Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 67 boxes of SYMPROIC (naldemedine) 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. The hazard involves storage temperature excursions, which is a quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 67 boxes of SYMPROIC (naldemedine) tablets, 0.2 mg, 30-count bottles. The recall is being conducted due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 59385-041-30 and code 2003060A. The distribution pattern for these units includes Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SYMPROIC (NALDEMEDINE)
- Brand
- SYMPROIC
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 67
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)
- 2003060A
UPCs (1)
- 0359385041307
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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