NAFCILLIN SODIUM Recall D-0764-2023
Description: Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
NAFCILLIN SODIUM Recall D-0764-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0764-2023 |
| Event ID | 92376 |
| Brand | NAFCILLIN |
| Generic Name | NAFCILLIN SODIUM |
| Manufacturer | NAFCILLIN SODIUM |
| Original Package? | 1 |
| Active Substance | NAFCILLIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide USA |
| Quantity | 370,200 bottles |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230531 |
| Product NDC | 25021-141 |
| Recall Initiation Date | 20230519 |
| Report Date | 20230531 |
| Classification Date | 20230523 |
| Address | 1901 N Roselle Rd Ste 450 Schaumburg, IL 60195-3194 United States |
| Recalling Firm | Sagent Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 49G3001BCK |
| Drug Application Number | ANDA090580 |
| Structured Product Labeling (SPL ID) | 9acd3c53-9e83-4462-b8cc-6299085640d1 |
| Structured Product Labeling (SPL Set ID) | 5a501234-5e1c-441f-be97-97add6eabb13 |
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