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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: CTA210006, Exp. 02/2024
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AuroMedics Pharma LLC
- Reason for Recall:
- Presence of Particulate Matter: Piece of metal found in a vial
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot: CTA210006, Exp. 02/2024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1551-2022
Related Recalls
Subpotent Drug: Out of specification for assay
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot