PIPERACILLIN SODIUM Recall D-0629-2023
Description: Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
PIPERACILLIN SODIUM Recall D-0629-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0629-2023 |
| Event ID | 92341 |
| Brand | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM |
| Generic Name | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM |
| Manufacturer | PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM |
| Original Package? | 1 |
| Active Substance | PIPERACILLIN SODIUM TAZOBACTAM SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | 169,520 Vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 70594-078 70594-079 70594-080 |
| 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 | M98T69Q7HP UXA545ABTT |
| Drug Application Number | ANDA212287 |
| Structured Product Labeling (SPL ID) | 7b8413a0-a8bd-4899-8567-677034eb0a7d |
| Structured Product Labeling (SPL Set ID) | 184b5961-1ae7-474c-afaa-2a2b2ccfc9cd |
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