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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0627-2023
Event ID92341
BrandPIPERACILLIN AND TAZOBACTAM
Generic NamePIPERACILLIN AND TAZOBACTAM
ManufacturerPIPERACILLIN AND TAZOBACTAM
Original Package?1
Active SubstancePIPERACILLIN SODIUM TAZOBACTAM SODIUM
Drug RouteINTRAVENOUS
DistributionNationwide within the United States
Quantity223,590 vials
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20230524
Product NDC66794-216 66794-217 66794-218
Recall Initiation Date20230515
Report Date20230524
Classification Date20230518
Address911 G I D C Makarpura
Vadodara,  
India
Recalling FirmAstral SteriTech Private Ltd.
Initial Notification Letter
Unique Ingredient IdentifierM98T69Q7HP UXA545ABTT
Drug Application NumberANDA212287
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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