Rivastigmine Transdermal Patch Recalled Due to Temperature Exposure
Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.
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 recall involving temperature exposure of a pharmaceutical medication. Although no adverse events have been reported, temperature-exposed pharmaceuticals present a known risk of reduced drug efficacy, which is particularly concerning for Alzheimer's patients requiring consistent dosing.
Plain-English summary
Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) in batch P0248AL0AT due to manufacturing deviations.
The patches were exposed to temperatures outside the labeled storage conditions, which could affect the quality and effectiveness of the product.
The affected product has been distributed nationwide. Patients currently using patches from this batch should contact their healthcare provider or pharmacist for guidance, including whether their prescription should be replaced.
The recalled product
- Product
- RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Transdermal Patch
- Hazard
- temperature-exposure
- improper-storage
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 P0248AL0AT
Distribution
Distributed nationwide across the United States.
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