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D-0522-2020 Class III Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0522-2020 was initiated by AuroMedics Pharma LLC on Nov 11, 2019 and is designated Class III. Reason for recall: Crystallization: Presence of visible particulate matter. The recall status is terminated (terminated Apr 1, 2021). Affected quantity: 138,720 vials.

Recall Details

Product Type: Drugs
Report Date: Dec 4, 2019
Initiation Date: Nov 11, 2019
Termination Date: Apr 1, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 138,720 vials

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.

Distribution Pattern

Distributed Nationwide in the US

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0522-2020
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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