AMIODARONE HYDROCHLORIDE
Generic: AMIODARONE HYDROCHLORIDE
Slate Run PharmaceuticalsManufacturer
INTRAVENOUSRoute
AMIODARONE HYDROCHLORIDEActive Substance
2024-09-11Original Approval
AMIODARONE HYDROCHLORIDE is FDA application ANDA218253, sponsored by ZHEJIANG POLY PHARM. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2014-09-12
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan InstitutionaTemperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room t
Class III2019-11-11
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuCrystallization: Presence of visible particulate matter.
Class III2019-11-11
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuCrystallization: Presence of visible particulate matter.
Class I2020-08-17
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL SinLabeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain v
Class III2019-11-11
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed bCrystallization: Presence of visible particulate matter.
Top Reported Reactions
1
DYSPNOEA
969 reports
2
OFF LABEL USE
851 reports
3
ASTHENIA
818 reports
4
FATIGUE
745 reports
5
DRUG INEFFECTIVE
671 reports
6
PRODUCT USE IN UNAPPROVED INDICATION
634 reports
7
NAUSEA
525 reports
8
COUGH
519 reports
9
DIZZINESS
453 reports
10
ATRIAL FIBRILLATION
451 reports