Warfarin Sodium tablets recalled due to improper storage temperature exposure
Cardinal Healthcare recalls Warfarin Sodium tablets distributed nationwide due to products being exposed to improper storage temperatures.
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: This is an FDA Class II drug recall involving a critical anticoagulant medication. Although no illnesses or injuries have been reported, the CGMP deviation involving improper storage temperature exposure creates a theoretical risk to drug potency and efficacy, meeting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
Cardinal Healthcare, the manufacturer for Teva Pharmaceuticals, is recalling Warfarin Sodium Tablets, USP 2.5 mg (Batch 2169041) distributed nationwide. The recall was initiated due to a manufacturing compliance issue: these products were exposed to temperatures outside of the manufacturer's labeled storage conditions.
Warfarin is a prescription anticoagulant (blood thinner) medication. Storage temperature control is critical to maintain drug potency. Exposure to improper temperatures may compromise the medication's quality and effectiveness.
Affected product includes NDC 0093-1714-01 and related package codes. Consumers with medication from this batch should contact their pharmacy or healthcare provider to determine if their supply is affected and to arrange for a replacement if necessary.
The recalled product
- Product
- WARFARIN SODIUM (WARFARIN SODIUM)
- Brand
- WARFARIN SODIUM
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Anticoagulant
- Hazard
- storage-deviation
- drug-efficacy
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 2169041
UPCs (6)
- 0300931721013
- 0300931713018
- 0300931714015
- 0300931723017
- 0300931716019
- 0300931715012
Distribution
Distributed nationwide across the United States.
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