FDAFDA · Food and drugs·Recall number D-1551-2022
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
Published October 12, 2022 · Recall initiated: September 26, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Piece of metal found in a vial
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TRANEXAMIC ACID
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0355150188109
- Lot
- Lot: CTA210006, Exp. 02/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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