CLONAZEPAM Recall D-0179-2025
Description: Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
CLONAZEPAM Recall D-0179-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0179-2025 |
| Event ID | 95778 |
| Brand | CLONAZEPAM |
| Generic Name | CLONAZEPAM |
| Manufacturer | CLONAZEPAM |
| Original Package? | 1 |
| Active Substance | CLONAZEPAM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 8,029 cartons |
| Recall Reason | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. |
| Drug Classification | Class I |
| Drug Code Info | 20250115 |
| Product NDC | 49884-306 49884-307 49884-308 |
| Product NUI | N0000175694 M0002356 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20241118 |
| Report Date | 20250115 |
| Classification Date | 20250103 |
| Address | 1400 Atwater Dr Malvern, PA 19355-8701 United States |
| Recalling Firm | Endo USA, Inc. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 5PE9FDE8GB |
| Drug Application Number | ANDA077171 |
| Structured Product Labeling (SPL ID) | e5490985-2ccf-428e-960e-e78fa887f258 |
| Structured Product Labeling (SPL Set ID) | 1aef0069-80ea-483d-ac70-c8d485462c5b |
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