IBUPROFEN Recall D-0047-2025
Description: IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
IBUPROFEN Recall D-0047-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0047-2025 |
| Event ID | 95620 |
| Brand | IBU |
| Generic Name | IBUPROFEN |
| Manufacturer | IBUPROFEN |
| Original Package? | 1 |
| Active Substance | IBUPROFEN |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 3416 botttles |
| Recall Reason | Failed Tablet/Capsule Specifications |
| Drug Classification | Class III |
| Drug Code Info | 20241127 |
| Product NDC | 55111-682 55111-683 55111-684 |
| Product NUI | N0000000160 M0001335 N0000175722 |
| Drug UPC | 0355111682011 0355111684015 0355111683018 |
| Pharma Class (EPC) | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Pharma Class (CS) | Anti-Inflammatory Agents, Non-Steroidal [CS] |
| Recall Initiation Date | 20241029 |
| Report Date | 20241127 |
| Classification Date | 20241115 |
| Address | 107 College Rd EN/A Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | N/A |
| Unique Ingredient Identifier | WK2XYI10QM |
| Drug Application Number | ANDA075682 |
| Structured Product Labeling (SPL ID) | f40df6f6-bb6a-f425-932f-4791f253a9d7 |
| Structured Product Labeling (SPL Set ID) | 24731405-219c-79b4-ecf0-7d5fbfda94ba |
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