ASPIRIN Recall D-0170-2024
Description: Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
ASPIRIN Recall D-0170-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0170-2024 |
| Event ID | 89450 |
| Brand | ASPIRIN |
| Generic Name | ASPIRIN |
| Manufacturer | ASPIRIN |
| Original Package? | 1 |
| Active Substance | ASPIRIN |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 2 units |
| 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 | 0536-1234 |
| Product NUI | N0000000160 N0000008836 M0001335 |
| Drug UPC | 0305361234416 |
| Pharma Class (PE) | Decreased Prostaglandin Production [PE] |
| Pharma Class (EPC) | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Pharma Class (CS) | Anti-Inflammatory Agents, Non-Steroidal [CS] |
| 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 | R16CO5Y76E |
| Drug Application Number | M013 |
| Structured Product Labeling (SPL ID) | 19dad4bc-c980-45c0-9eb5-a8f47184e08e |
| Structured Product Labeling (SPL Set ID) | 63fcd93a-b1db-44ba-8f2b-055a7deb205d |
| Similar To |