Reported Oct 12, 2022 · Ongoing
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by:…
AuroMedics Pharma LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only
- Distributed byAuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
- Lot codes and dates
- Lot
CTA210006Exp. 02/2024
- Lot
- Amount recalled
- 88080 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: Piece of metal found in a vial
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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