PHENYTOIN Recall D-0153-2024
Description: Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
PHENYTOIN Recall D-0153-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0153-2024 |
| Event ID | 93224 |
| Brand | PHENYTOIN |
| Generic Name | PHENYTOIN |
| Manufacturer | PHENYTOIN |
| Active Substance | PHENYTOIN |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 3718 saleable units |
| Recall Reason | Failed Content Uniformity Specifications |
| Drug Classification | Class I |
| Drug Code Info | 20231227 |
| Product NDC | 0904-7079 |
| Product NUI | N0000175753 N0000008486 N0000191266 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Pharma Class (EPC) | Anti-epileptic Agent [EPC] |
| Recall Initiation Date | 20231023 |
| Report Date | 20231227 |
| Classification Date | 20231220 |
| Address | 341 Mason Rd 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 | 6158TKW0C5 |
| Drug Application Number | ANDA040521 |
| Structured Product Labeling (SPL ID) | 070e56f4-db77-4ead-aad9-054a1dad8507 |
| Structured Product Labeling (SPL Set ID) | 76c93365-7aa0-430a-9f49-e94e10912f49 |
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