Drug recall D-1575-2020
Product
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), 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.
Lots and codes
Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
Recall details
- Recalling firm
- Mylan Institutional LLC, Rockford, IL
- Quantity
- 13,682 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 17, 2020
- Terminated
- December 28, 2022
Related products
- Amiodarone Hydrochloride – drug information
- NDC 67457-153 Amiodarone Hydrochloride · Amiodarone Hydrochloride 50 mg/mL · Mylan Institutional LLC