Tranexamic Acid Injection recall: Particulate Matter
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
Why was Tranexamic Acid Injection recalled?
Presence of Particulate Matter: Piece of metal found in a vial
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: CTA210006, Exp. 02/2024
- 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
- Recalling firm
- AuroMedics Pharma LLC
- Quantity
- 88080 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- October 12, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)