Tranexamic Acid Injection — Class I drug recall D-1576-2020
Terminated recall by Mylan Institutional LLC, reported 2020-09-09, distributed nationwide. Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Am
| Recall number | D-1576-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2020-08-17 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-09 |
| Terminated | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,407 cartons |
| Reason classes | labeling |
| NDC | 67457-0197, 67457-0197-00, 67457-0197-10 |
| Lot numbers | 191207, 191221, 191223, 200120 |
| Expiration dates | 2021-11, 2021-12 |
Product
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
Reason for recall
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
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-1576-2020. 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.