CEFTRIAXONE SODIUM Recall D-0620-2023
Description: Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
CEFTRIAXONE SODIUM Recall D-0620-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0620-2023 |
| Event ID | 92341 |
| Brand | CEFTRIAXONE |
| Generic Name | CEFTRIAXONE |
| Manufacturer | CEFTRIAXONE |
| Original Package? | 1 |
| Active Substance | CEFTRIAXONE SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | 7,940 bottles |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 70594-098 |
| Recall Initiation Date | 20230515 |
| Report Date | 20230524 |
| Classification Date | 20230518 |
| Address | 911 G I D C Makarpura Vadodara, India |
| Recalling Firm | Astral SteriTech Private Ltd. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 023Z5BR09K |
| Drug Application Number | ANDA091117 |
| Structured Product Labeling (SPL ID) | d4819f4d-0e62-4647-b642-2727358f8727 |
| Structured Product Labeling (SPL Set ID) | 856be1ac-03a6-47be-b4a8-e9e8e7c87da5 |
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