ACETAZOLAMIDE Recall D-0659-2024
Description: AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
ACETAZOLAMIDE Recall D-0659-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0659-2024 |
| Event ID | 95217 |
| Brand | ACETAZOLAMIDE |
| Generic Name | ACETAZOLAMIDE |
| Manufacturer | ACETAZOLAMIDE |
| Original Package? | 1 |
| Active Substance | ACETAZOLAMIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the US |
| Quantity | 3,984 bottles |
| Recall Reason | Discoloration |
| Drug Classification | Class III |
| Drug Code Info | 20240925 |
| Product NDC | 72888-047 72888-048 |
| Product NUI | N0000175517 N0000000235 M0020790 |
| Drug UPC | 0372888048017 0372888047010 |
| Pharma Class (EPC) | Carbonic Anhydrase Inhibitor [EPC] |
| Pharma Class (CS) | Sulfonamides [CS] |
| Recall Initiation Date | 20240824 |
| Report Date | 20240925 |
| Classification Date | 20240913 |
| Address | 4 & K30 5 Plot No K - 30 Ambarnath, N/A India |
| Recalling Firm | Rubicon Research Private Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | O3FX965V0I |
| Drug Application Number | ANDA215101 |
| Structured Product Labeling (SPL ID) | ca978199-e02f-6021-e053-2a95a90a74ed |
| Structured Product Labeling (SPL Set ID) | c24d31f0-a556-4e53-97a9-4e05e28ca40f |
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