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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1551-2022 |
Event ID | 90897 |
Brand | TRANEXAMIC ACID |
Generic Name | TRANEXAMIC ACID |
Manufacturer | TRANEXAMIC ACID |
Original Package? | 1 |
Active Substance | TRANEXAMIC ACID |
Drug Route | INTRAVENOUS |
Distribution | Distributed Nationwide in the USA |
Quantity | 88080 vials |
Recall Reason | Presence of Particulate Matter: Piece of metal found in a vial |
Drug Classification | Class III |
Drug Code Info | 20221012 |
Product NDC | 55150-188 |
Product NUI | N0000175634 N0000175632 |
Pharma Class (PE) | Decreased Fibrinolysis [PE] |
Pharma Class (EPC) | Antifibrinolytic Agent [EPC] |
Recall Initiation Date | 20220926 |
Report Date | 20221012 |
Classification Date | 20220930 |
Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
Recalling Firm | AuroMedics Pharma LLC |
Initial Notification | Letter |
Unique Ingredient Identifier | 6T84R30KC1 |
Drug Application Number | ANDA205035 |
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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