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Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial,...

FDA Recall #D-0522-2020 — Class III — November 11, 2019

Recall #D-0522-2020 Date: November 11, 2019 Classification: Class III Status: Terminated

Product Description

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

Reason for Recall

Crystallization: Presence of visible particulate matter.

Recalling Firm

AuroMedics Pharma LLC — East Windsor, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

138,720 vials

Distribution

Distributed Nationwide in the US

Code Information

Lot#: CAH180013, CAH180014, exp. date Jul 2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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