CLASS III Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report
Amiodarone Hydrochloride Injection, USP, 150 mg recalled
AuroMedics Pharma is recalling Amiodarone Hydrochloride Injection, USP, 150 mg per (50 mg / mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 11 Nov 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0520-2020
- FDA event ID
- 84240
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Manufacturer
- AuroMedics Pharma LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Nov 2019
- FDA classified
- 22 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Nov 2019 | Recall initiated by company | |
| 22 Nov 2019 | Classified by FDA | +11 days |
| 4 Dec 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization: Presence of visible particulate matter.
Product as listed by the FDA
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03
Where it was distributed
Distributed Nationwide in the US
Questions about this recall
Why was it recalled?
Crystallization: Presence of visible particulate matter.
Which lots are affected?
Lot# CAH180009, exp. date Feb 2020
Where was it sold?
Distributed Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84240| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide | |
| CLASS III | Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
Other Amiodarone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | Mylan Institutional | Packaging Defects | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Nexterone (amiodarone HCl) Premixed Injection, 150mg recalledNexterone | Baxter Healthcare | Particulate Matter | Nationwide |