FDAFDA · Food and drugs·Recall number D-0520-2020
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
Published December 4, 2019 · Recall initiated: November 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: Presence of visible particulate matter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Distributed Nationwide in the US
- UPC
- 0355150180035
- Lot
- Lot# CAH180009, exp. date Feb 2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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