LORAZEPAM Recall D-0226-2025
Description: Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
LORAZEPAM Recall D-0226-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0226-2025 |
| Event ID | 96151 |
| Brand | LORAZEPAM |
| Generic Name | LORAZEPAM |
| Manufacturer | LORAZEPAM |
| Active Substance | LORAZEPAM |
| Drug Route | ORAL |
| Distribution | Nationwide U.S. and Puerto rico |
| Quantity | 82,281 cartons |
| Recall Reason | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. |
| Drug Classification | Class II |
| Drug Code Info | 20250226 |
| Product NDC | 0904-6007 0904-6008 0904-6009 |
| Product NUI | N0000175694 M0002356 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20250121 |
| Report Date | 20250226 |
| Classification Date | 20250219 |
| Address | 341 Mason RdN/A La Vergne, TN 37086-3606 United States |
| Recalling Firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Initial Notification | Letter |
| Unique Ingredient Identifier | O26FZP769L |
| Drug Application Number | ANDA078203 |
| Structured Product Labeling (SPL ID) | 6b6c2fbc-d12d-41d7-b49d-cf374c773cbd |
| Structured Product Labeling (SPL Set ID) | 62f6eb3b-813d-4890-aca9-799b7fa890df |
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