Warfarin Sodium Tablets Recalled Due to Temperature Storage Deviation
Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a prescription drug with manufacturing deviations affecting product storage conditions. No illnesses or injuries have been reported. The hazard is theoretical, consistent with a 'High' severity score—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Healthcare is recalling Warfarin Sodium Tablets, USP, 5 mg (batch 2323041) distributed nationwide. Warfarin is a prescription anticoagulant used to help prevent blood clots.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The company identified that products were exposed to temperatures outside of the labeled storage conditions.
Patients currently taking Warfarin should not stop taking their medication without consulting their healthcare provider. Those who believe they may have received tablets from the recalled batch should contact their pharmacy or healthcare provider. Cardinal Healthcare and healthcare providers are working to identify affected distributions.
Patients and healthcare providers should report any adverse effects related to this product to the FDA MedWatch program.
The recalled product
- Product
- WARFARIN SODIUM (WARFARIN SODIUM)
- Brand
- WARFARIN SODIUM
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Anticoagulant
- Hazard
- storage-temperature-deviation
- cgmp-deviation
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)
- Batch 2323041
UPCs (6)
- 0300931721013
- 0300931713018
- 0300931714015
- 0300931723017
- 0300931716019
- 0300931715012
Distribution
Distributed nationwide across the United States.
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- HighWarfarin Sodium tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03
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