FDA Drug Class III — Least Serious

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

Hazard

Crystallization: Presence of visible particulate matter.

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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
Brand
AuroMedics Pharma LLC
UPC
Lot#: CAH180013, CAH180014, exp. date Jul 2020

Units Affected

138,720 vials

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