OXACILLIN SODIUM Recall D-0935-2023
Description: Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
OXACILLIN SODIUM Recall D-0935-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0935-2023 |
| Event ID | 92678 |
| Brand | OXACILLIN |
| Generic Name | OXACILLIN SODIUM |
| Manufacturer | OXACILLIN SODIUM |
| Original Package? | 1 |
| Active Substance | OXACILLIN SODIUM |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA |
| Quantity | 65,710 vials for 1 g and 2 g strength |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230802 |
| Product NDC | 25021-146 25021-162 |
| Recall Initiation Date | 20230711 |
| Report Date | 20230802 |
| Classification Date | 20230721 |
| Address | 1901 N Roselle Rd Ste 450 Schaumburg, IL 60195-3194 United States |
| Recalling Firm | Sagent Pharmaceuticals |
| Initial Notification | Letter |
| Unique Ingredient Identifier | G0V6C994Q5 |
| Drug Application Number | ANDA091246 |
| Structured Product Labeling (SPL ID) | d20bc39b-1c49-4dd7-8cde-2edcfe061c76 |
| Structured Product Labeling (SPL Set ID) | f3bee4d7-82d8-4e2d-8fc8-4446e6fbf999 |
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