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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