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
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE 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.
See all 42 products in this recall →Related recalls
Same manufacturer · CARDINAL HEALTHCARE
See all →- HighAlbuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateMeloxicam 15 mg tablets recalled for exposure to improper storage temperatures
FDA (Drugs) · 2024-01-03
- HighPredniSONE Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighLow-dose aspirin recall due to improper storage temperature conditions
FDA (Drugs) · 2024-01-03
- HighBumetanide Tablets Recalled for Exposure to Improper Storage Temperatures
FDA (Drugs) · 2024-01-03
Same hazard · temperature exposure
See all →- ModerateQuantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
FDA (Devices) · 2024-10-30
- HighRespiratory inhalation medication recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- ModerateAllopurinol tablets recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
- HighAmoxicillin tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03