FDA Drug recall D-1576-2020
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00)
- FDA Drug
- Class I
- terminated
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class I recall of Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00) by Mylan Institutional, citing 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 Inj….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1576-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-08-17 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional |
| Distribution | US |
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
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.
Identifiers
| ndc | 67457-197-00 |
|---|---|
| ndc | 67457-197-10 |
| code_info | Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1576-2020%22
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