Multi event Drug Recall Enforcement Report Class II voluntary initiated by Sagent Pharmaceuticals Inc, originally initiated on 05-19-2023 for the product Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
D-0764-2023 | 05-19-2023 | 05-31-2023 | Class II | 370,200 bottles | Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 | Lack of Assurance of Sterility | Ongoing |
D-0762-2023 | 05-19-2023 | 05-31-2023 | Class II | 2,249,980 vials | Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10 | Lack of Assurance of Sterility | Ongoing |
D-0763-2023 | 05-19-2023 | 05-31-2023 | Class II | 2,249,980 vials | Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10 | Lack of Assurance of Sterility | Ongoing |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
25021-139 | Nafcillin | Nafcillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | Sagent Pharmaceuticals | Human Prescription Drug |
25021-140 | Nafcillin | Nafcillin Sodium | Injection, Powder, For Solution | Intramuscular; Intravenous | Sagent Pharmaceuticals | Human Prescription Drug |
25021-141 | Nafcillin | Nafcillin Sodium | Injection, Powder, For Solution | Intravenous | Sagent Pharmaceuticals | Human Prescription Drug |