IBUPROFEN Recall D-0644-2024
Description: IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
IBUPROFEN Recall D-0644-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0644-2024 |
| Event ID | 95098 |
| Brand | IBU |
| Generic Name | IBUPROFEN |
| Manufacturer | IBUPROFEN |
| Original Package? | 1 |
| Active Substance | IBUPROFEN |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 103,298 bottles |
| Recall Reason | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. |
| Drug Classification | Class II |
| Drug Code Info | 20240904 |
| 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 | 20240806 |
| Report Date | 20240904 |
| Classification Date | 20240826 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Unique Ingredient Identifier | WK2XYI10QM |
| Drug Application Number | ANDA075682 |
| Structured Product Labeling (SPL ID) | c102040d-6d3a-1ca8-f426-ce99be7d7902 |
| Structured Product Labeling (SPL Set ID) | 24731405-219c-79b4-ecf0-7d5fbfda94ba |
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