Use cautionDrug recall · FDA · Published September 26, 2022
AuroMedics Tranexamic Acid Injection Recall: Metal Particulate Hazard
AuroMedics Pharma LLC recalls Tranexamic Acid 1000mg/10mL vials due to metal particles found in some batches. This could cause injury during injection. Return or discard affected vials immediately.
“AuroMedics Tranexamic Acid Injection Recall: Metal Particulate Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34314-auromedics-tranexamic-acid-injection-recall-metal-particulate-hazard. Based on FDA recall #D-1551-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1551-2022%22&limit=1).
AuroMedics Pharma LLC, on behalf of the Food and Drug Administration, recalled Tranexamic Acid Injection, USP due to metal particulate matter in vials. The agency announced the Class III voluntary recall on September 26, 2022.
How to tell if you have it
Brand: AuroMedics
Product: Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial
NDC: 55150-188-10
Lot code: CTA210006
Expiration date: 02/2024
Quantity: 88,080 vials
The hazard
The recall addresses the presence of particulate matter, specifically a piece of metal found in a vial. The FDA classified this as a Class III hazard.
Context
GovInfoNow's records show AuroMedics Pharma LLC has 22 other recalls on record since December 4, 2017. Recent similar recalls include the September 30, 2022 Fondaparinux Injection recall for subpotent drug risk and the September 26, 2022 Acyclovir Injection recall for particulate matter hazard. Other recent recalls of similar products include the August 11, 2026 American Regent Epinephrine Injection recall for particulate matter risk and the July 17, 2026 Sunny Pharmtech Cyclophosphamide Injection recall for stainless steel particulate risk.
How to tell if you have this one
Check for the lot number CTA210006 on the vial label. The vial expires February 2024 and was made in India. This product is only available by prescription.
Brand
AuroMedics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Label
Look for the lot number CTA210006 and expiration date of 02/2024 on the vial.
Discard or Return Vial
If the vial has the lot number CTA210006, discard it immediately or contact your doctor for instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1551-2022 (September 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1551-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.