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

FDA recall notice · announced October 12, 2022 · Auromedics Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Presence of Particulate Matter: Piece of metal found in a vial

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot: CTA210006, Exp. 02/2024
Quantity: 88080 vials
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.