PHENYTOIN SODIUM Recall D-0090-2024
Description: Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
PHENYTOIN SODIUM Recall D-0090-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0090-2024 |
| Event ID | 93292 |
| Brand | EXTENDED PHENYTOIN SODIUM |
| Generic Name | PHENYTOIN SODIUM |
| Manufacturer | PHENYTOIN SODIUM |
| Original Package? | 1 |
| Active Substance | PHENYTOIN SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 9,263 100-count bottles |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20231115 |
| Product NDC | 65162-212 |
| Drug UPC | 0365162212037 0365162212105 |
| Recall Initiation Date | 20231027 |
| Report Date | 20231115 |
| Classification Date | 20231107 |
| Address | 50 Horseblock Rd Brookhaven, NY 11719-9509 United States |
| Recalling Firm | Amneal Pharmaceuticals of New York, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4182431BJH |
| Drug Application Number | ANDA040765 |
| Structured Product Labeling (SPL ID) | f629af5d-faef-4416-9b98-55a3a5ec8271 |
| Structured Product Labeling (SPL Set ID) | 7e467c02-49a0-4b62-b537-430fdfa4f10e |
| Similar To |