PIPERACILLIN SODIUM Recall D-0622-2023
Description: Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
PIPERACILLIN SODIUM Recall D-0622-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0622-2023 |
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 | 204,860 vials |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20230524 |
Product NDC | 72572-575 72572-576 72572-577 |
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) | 2919e37d-528c-413a-aad3-eb5d116718ae |
Structured Product Labeling (SPL Set ID) | 17264f43-cafa-41d2-b653-cad6d73740ca |
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