RIVASTIGMINE Recall D-0196-2024
Description: 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
RIVASTIGMINE Recall D-0196-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0196-2024 |
| Event ID | 89450 |
| Brand | RIVASTIGMINE TRANSDERMAL SYSTEM |
| Generic Name | RIVASTIGMINE TRANSDERMAL SYSTEM |
| Manufacturer | RIVASTIGMINE TRANSDERMAL SYSTEM |
| Original Package? | 1 |
| Active Substance | RIVASTIGMINE |
| Drug Route | TRANSDERMAL |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 47781-304 47781-305 47781-405 |
| Product NUI | N0000175723 N0000000177 |
| Pharma Class (EPC) | Cholinesterase Inhibitor [EPC] |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | PKI06M3IW0 |
| Drug Application Number | ANDA204403 |
| Structured Product Labeling (SPL ID) | ba92f242-fdc3-c9e9-71ce-0f2a7be4c1d0 |
| Structured Product Labeling (SPL Set ID) | 11d4ef03-33d2-359e-2053-4102630b27ba |
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