Class I
Terminated
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.
- Company
- Mylan Institutional Llc
- Recall Initiated
- August 17, 2020
- Posted
- September 9, 2020
- Recall Number
- D-1575-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,682 cartons
- Firm Location
- Rockford, IL, United States
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
Nationwide
Lot / Code Info
Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
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