FDA Drug Recalls

Recalls / Brands / Amiodarone Hydrochloride

Amiodarone Hydrochloride

5 FDA drug recalls involving brand “Amiodarone Hydrochloride” — 1 Class I.

DateClassProductFirm
2020-08-17Class IAmiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 Mylan Institutional LLC
2019-11-11Class IIIAmiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, DistribAuroMedics Pharma LLC
2019-11-11Class IIIAmiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, DistribAuroMedics Pharma LLC
2019-11-11Class IIIAmiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, DisAuroMedics Pharma LLC
2014-09-12Class IIAmiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan InMckesson