AMPICILLIN SODIUM Recall D-0586-2023
Description: Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
AMPICILLIN SODIUM Recall D-0586-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0586-2023 |
| Event ID | 92341 |
| Brand | AMPICILLIN |
| Generic Name | AMPICILLIN SODIUM |
| Manufacturer | AMPICILLIN SODIUM |
| Original Package? | 1 |
| Active Substance | AMPICILLIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | 59,530 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 70594-084 70594-085 70594-086 |
| 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 | JFN36L5S8K |
| Drug Application Number | ANDA090583 |
| Structured Product Labeling (SPL ID) | 2c29bd08-f467-4028-aac6-0a5b3007a5d3 |
| Structured Product Labeling (SPL Set ID) | 94421dac-7865-49f8-ae52-871eee6465ac |
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