AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter
AuroMedics Pharma LLC is recalling 28,810 vials of Amiodarone Hydrochloride Injection due to the presence of visible particulate matter.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
AuroMedics Pharma LLC is recalling 28,810 vials of Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial. The product is distributed nationwide in the US and is identified by Lot# CAH180009 with an expiration date of Feb 2020.
The recall was initiated because of the presence of visible particulate matter, described as crystallization. This is a Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences.
Patients and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injection
- Affected units
- 28,810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# CAH180009
- exp. date Feb 2020
UPCs (3)
- 0355150180035
- 0355150182183
- 0355150181094
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by AuroMedics Pharma LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · AMIODARONE HYDROCHLORIDE
- CriticalMylan Recalls Amiodarone Hydrochloride Injection Due to Labeling Mix-Up
FDA (Drugs) · 2020-09-09
- LowAuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter
FDA (Drugs) · 2019-12-04
- LowAuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter
FDA (Drugs) · 2019-12-04
- ModerateMylan Amiodarone Hydrochloride Injection Recalled for Temperature Abuse
FDA (Drugs) · 2014-10-15
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