The Recall Desk
LowFDA (Drugs)·D-0522-2020·Announced 2019-12-04

AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

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 FDA classified this recall as 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. The hazard is limited to visible particulate matter without reported injuries.

Plain-English summary

AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vials. The recall is being conducted because of the presence of visible particulate matter, described in the source as crystallization. The affected product is identified by Lot numbers CAH180013 and CAH180014, with an expiration date of July 2020. The NDC for the recalled product is 55150-182-18.

The recall involves 138,720 vials that were distributed nationwide in the United States. The product is a prescription-only medication manufactured in India and distributed by AuroMedics Pharma LLC in E. Windsor, NJ. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected lots of Amiodarone Hydrochloride Injection. Consumers should check their medication vials for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement according to their instructions.

The recalled product

Product
AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
Brand
AMIODARONE HYDROCHLORIDE
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Injection
Hazard
Affected units
138,720

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 (3)

  • Lot#: CAH180013
  • CAH180014
  • exp. date Jul 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

Same manufacturer · AuroMedics Pharma LLC

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Same hazard · particulate matter

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