CLOBAZAM Recall D-0201-2025
Description: Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
CLOBAZAM Recall D-0201-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0201-2025 |
| Event ID | 96117 |
| Brand | CLOBAZAM |
| Generic Name | CLOBAZAM |
| Manufacturer | CLOBAZAM |
| Active Substance | CLOBAZAM |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 4640 units |
| Recall Reason | Presence of Foreign Tablets/Capsules |
| Drug Classification | Class II |
| Drug Code Info | 20250122 |
| Product NDC | 60687-423 |
| Product NUI | N0000175694 M0002356 N0000182137 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20250107 |
| Report Date | 20250122 |
| Classification Date | 20250114 |
| Address | 2550 John Glenn Ave Ste A Columbus, OH 43217-1188 United States |
| Recalling Firm | Amerisource Health Services LLC |
| Unique Ingredient Identifier | 2MRO291B4U |
| Drug Application Number | ANDA209718 |
| Structured Product Labeling (SPL ID) | 2439cdd1-e240-530e-e063-6394a90ab78e |
| Structured Product Labeling (SPL Set ID) | 8fce3252-95f8-4428-9922-5ba308e20177 |
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