Drug 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.
D-1575-2020
Product summary
- Event
- Event 86247
- Status
- Terminated
- Classification
- Class I
- Quantity
- 13,682 cartons
- Official record key
drug-enforcement:D-1575-2020
Official wording
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.
Code information: Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up