Recalls / Class III
Class IIID-1551-2022
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
- Brand name
- Tranexamic Acid
- Generic name
- Tranexamic Acid
- Active ingredient
- Tranexamic Acid
- Route
- Intravenous
- NDC
- 55150-188
- FDA application
- ANDA205035
- Affected lot / code info
- Lot: CTA210006, Exp. 02/2024
Why it was recalled
Presence of Particulate Matter: Piece of metal found in a vial
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 88080 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-09-26
- FDA classified
- 2022-09-30
- Posted by FDA
- 2022-10-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1551-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.