Recalls / Class II
Class IID-0196-2024
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
- Affected lot / code info
- Batch P0248AL0AT
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm
- Firm
- CARDINAL HEALTHCARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7200 Cardinal Pl W, Dublin, Ohio 43017-1094
Distribution
- Quantity
- 1 unit
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0196-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.