Recalls / Generics / Amiodarone Hydrochloride
Amiodarone Hydrochloride
6 FDA drug recalls involving generic “Amiodarone Hydrochloride” — 2 Class I.
| Date | Class | Product | Firm |
|---|---|---|---|
| 2020-08-17 | Class I | Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 | Mylan Institutional LLC |
| 2019-11-11 | Class III | Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distrib | AuroMedics Pharma LLC |
| 2019-11-11 | Class III | Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distrib | AuroMedics Pharma LLC |
| 2019-11-11 | Class III | Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Dis | AuroMedics Pharma LLC |
| 2017-11-10 | Class I | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare C | Baxter Healthcare Corporation |
| 2014-09-12 | Class II | Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan In | Mckesson |