Home / Recalls / AuroMedics Pharma LLC / D-0521-2020

D-0521-2020 Class III Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0521-2020 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: 29,830 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: 29,830 vials

Product Description

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

Reason for Recall

Crystallization: Presence of visible particulate matter.

Distribution Pattern

Distributed Nationwide in the US

Code Information

Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0521-2020
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.

Other recalls by AuroMedics Pharma LLC

D-0020-2023 Class II — Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled… (Sep 30, 2022)
D-0013-2023 Class II — Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx… (Sep 26, 2022)
D-1551-2022 Class III — Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose… (Sep 26, 2022)
D-0556-2022 Class I — Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in… (Jan 26, 2022)
D-0248-2021 Class II — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial… (Dec 30, 2020)
D-0853-2020 Class III — Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose… (Feb 7, 2020)
D-0852-2020 Class II — Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count… (Feb 7, 2020)
D-0789-2020 Class III — Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For… (Dec 2, 2019)
D-0574-2020 Class II — Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count… (Nov 25, 2019)
D-0637-2020 Class I — Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by… (Nov 20, 2019)