PIPERACILLIN SODIUM Recall D-0627-2023
Description: Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
PIPERACILLIN SODIUM Recall D-0627-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0627-2023 |
| Event ID | 92341 |
| Brand | PIPERACILLIN AND TAZOBACTAM |
| Generic Name | PIPERACILLIN AND TAZOBACTAM |
| Manufacturer | PIPERACILLIN AND TAZOBACTAM |
| Original Package? | 1 |
| Active Substance | PIPERACILLIN SODIUM TAZOBACTAM SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | 223,590 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 66794-216 66794-217 66794-218 |
| 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) | f0ce0e63-c11e-3ce6-e053-2995a90a50f5 |
| Structured Product Labeling (SPL Set ID) | 876b22e3-de45-5ddc-e053-2a95a90ac886 |
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