Drug product
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
D-1551-2022
Product summary
- Event
- Event 90897
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 88080 vials
- Official record key
drug-enforcement:D-1551-2022
Official wording
Reason: Presence of Particulate Matter: Piece of metal found in a vial
Code information: Lot: CTA210006, Exp. 02/2024
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter