FDA Drug Class III — Least Serious

Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09

Hazard

Crystallization: Presence of visible particulate matter.

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Products

Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
Brand
AuroMedics Pharma LLC
UPC
Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020

Units Affected

29,830 vials

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