PIPERACILLIN SODIUM Recall D-0625-2023
Description: Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
PIPERACILLIN SODIUM Recall D-0625-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0625-2023 |
| Event ID | 92341 |
| Brand | PIPERACILLIN AND TAZOBACTAM |
| 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 | 249,080 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 71288-002 71288-003 71288-004 |
| 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) | ed3d8595-3996-4b0c-a550-5609f3d479ed |
| Structured Product Labeling (SPL Set ID) | 4e131a40-3928-4276-a706-0ebb9f064697 |
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