Tranexamic Acid Injection — Class III drug recall D-1551-2022
Ongoing recall by AuroMedics Pharma LLC, reported 2022-10-12, distributed nationwide. Presence of Particulate Matter: Piece of metal found in a vial
| Recall number | D-1551-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2022-09-26 |
| Classified | 2022-09-30 |
| Reported by FDA | 2022-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 88,080 vials |
| Reason classes | specification failure |
| NDC | 55150-0188, 55150-0188-10 |
| Lot numbers | CTA210006 |
| Expiration dates | 2024-02 |
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
Reason for recall
Presence of Particulate Matter: Piece of metal found in a vial
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1551-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.