Tranexamic Acid Injection recalled over possible metal fragments
- Recall date
- September 26, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedic…
- Recall number
- D-1551-2022
- FDA classification
- Class III
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Presence of Particulate Matter: Piece of metal found in a vial
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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