FDA-Drug2022-10-12Class III
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
AuroMedics Pharma LLC
Hazard
Presence of Particulate Matter: Piece of metal found in a vial
Sold states
Distributed Nationwide in the USA
Affected count
88080 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1551-2022Don't want to check this manually?
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