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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