CLASS III ONGOING Drug recall · Reported 12 Oct 2022 · FDA Enforcement Report
Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics Pharma
AuroMedics Pharma is recalling Tranexamic Acid Injection, USP, 1000mg per (100mg /mL) single-dose vial, distributed nationwide in the US. The recall was initiated on 26 Sep 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1551-2022
- FDA event ID
- 90897
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Tranexamic Acid
- Manufacturer
- Eugia US LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Sep 2022
- FDA classified
- 30 Sep 2022
- Reported
- 12 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Sep 2022 | Recall initiated by company | |
| 30 Sep 2022 | Classified by FDA | +4 days |
| 12 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Piece of metal found in a vial
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Tranexamic Acid Injection, USP, 1000mg per (100mg /mL) single-dose vial recalled?
Yes. AuroMedics Pharma recalled Tranexamic Acid Injection, USP, 1000mg per (100mg /mL) single-dose vial on 26 Sep 2022. The recall is Class III and its status is Ongoing. Recall number D-1551-2022.
Why was it recalled?
Presence of Particulate Matter: Piece of metal found in a vial
Which lots are affected?
Lot: CTA210006, Exp. 02/2024
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 4 mg per 2 mg/mL) Multiple Dose Vial recalledGlycopyrrolate | AuroMedics Pharma | Potency & Assay | LA, MS, OH |
Other Tranexamic Acid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARETranexamic Acid | AVKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Lysteda (tranexamic acid) USP Tablets, 650 mg recalledTranexamic Acid | Amring Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan InstitutionalTranexamic Acid | Mylan Institutional | Packaging Defects | Nationwide |
| Drug | CLASS II | Tranexamic Acid Injection USP, 1000mg/ vial recalled | Fresenius Kabi USA | Particulate Matter | Nationwide |