Why it was recalled
Presence of Particulate Matter: Piece of metal found in a vial
Product 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
Lot numbers, UPCs & expiration codes
Lot: CTA210006, Exp. 02/2024
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1551-2022
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 26, 2022
- FDA report date
- Oct 12, 2022
- Quantity
- 88080 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-1551-2022, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 90897
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot: CTA210006, Exp. 02/2024
- Postal code
- 08520-1401
- Report date
- Oct 12, 2022
- Product type
- Drugs
- Recall number
- D-1551-2022
- Classification
- Class III
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 88080 vials
- Reason for recall
- Presence of Particulate Matter: Piece of metal found in a vial
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Sep 26, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2022