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.
Plain-English summary
AuroMedics Pharma LLC is recalling specific lots of Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single 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 a prescription-only intravenous medication made in India and distributed by AuroMedics Pharma LLC in E. Windsor, NJ. The recall covers 29,830 vials from specific lots with expiration dates ranging from January 2020 to June 2020. These products were distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected vials and contact AuroMedics Pharma LLC for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 29,830
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 (7)
- Lot# CAH180001
- exp. date Jan 2020
- CAH180003
- exp. date Feb 2020
- CAH180011
- CAH180012
- exp. date Jun 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
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