Product Safety Recalls

Product Recall Tracker

TRANEXAMIC ACID Recall D-1551-2022

Description: Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg / 10mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

TRANEXAMIC ACID Recall D-1551-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1551-2022
Event ID90897
BrandTRANEXAMIC ACID
Generic NameTRANEXAMIC ACID
ManufacturerTRANEXAMIC ACID
Original Package?1
Active SubstanceTRANEXAMIC ACID
Drug RouteINTRAVENOUS
DistributionDistributed Nationwide in the USA
Quantity88080 vials
Recall ReasonPresence of Particulate Matter: Piece of metal found in a vial
Drug ClassificationClass III
Drug Code Info20221012
Product NDC55150-188
Product NUIN0000175634 N0000175632
Pharma Class (PE)Decreased Fibrinolysis [PE]
Pharma Class (EPC)Antifibrinolytic Agent [EPC]
Recall Initiation Date20220926
Report Date20221012
Classification Date20220930
Address279 Princeton Hightstown Rd
East Windsor, NJ 08520-1401
United States
Recalling FirmAuroMedics Pharma LLC
Initial Notification Letter
Unique Ingredient Identifier6T84R30KC1
Drug Application NumberANDA205035
Structured Product Labeling (SPL ID)0c59bf92-f331-44d7-b8ab-5b4b7adca98b
Structured Product Labeling (SPL Set ID)246a3c6c-a7fb-45c7-9509-49a48a5bdcc6
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