FDA-Drug2019-12-04Class III
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
AuroMedics Pharma LLC
Hazard
Crystallization: Presence of visible particulate matter.
Sold states
Distributed Nationwide in the US
Affected count
138,720 vials
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2020Don't want to check this manually?
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