FDAFDA · Food and drugs·Recall number D-1575-2020
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.
Published September 9, 2020 · Recall initiated: August 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- Mylan Institutional LLC
- Distributor
- Nationwide
- Lot
- Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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