Cardinal Health Recalls Sulindac Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 92 bottles of Sulindac 200mg 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 the hazard 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 92 bottles of Sulindac Tablets, USP, 200mg, 100-count bottles. The product is a prescription-only medication manufactured by Epic Pharma, LLC, and is identified by NDC 42806-011-01 and lot code 1578F201.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- SULINDAC (SULINDAC)
- Brand
- SULINDAC
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 92
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)
- 1578F201
UPCs (2)
- 0342806018057
- 0342806011010
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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