D-1576-2020 Class I Terminated
FDA drug recall D-1576-2020 was initiated by Mylan Institutional LLC on Aug 17, 2020 and is designated Class I. 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… The recall status is terminated (terminated Dec 28, 2022). Affected quantity: 1407 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 9, 2020
- Initiation Date
- Aug 17, 2020
- Termination Date
- Dec 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1407 cartons
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1576-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026