Drug recall D-0520-2020
Product
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
Reason for recall
Crystallization: Presence of visible particulate matter.
Lots and codes
Lot# CAH180009, exp. date Feb 2020
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 28,810 vials
- Distribution
- Distributed Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 11, 2019
- Terminated
- April 1, 2021
Related products
- Amiodarone Hydrochloride – drug information
- NDC 55150-181 Amiodarone Hydrochloride · Amiodarone Hydrochloride 450 mg/9mL · AuroMedics Pharma LLC
- NDC 55150-182 Amiodarone Hydrochloride · Amiodarone Hydrochloride 900 mg/18mL · AuroMedics Pharma LLC
- NDC 55150-180 Amiodarone Hydrochloride · Amiodarone Hydrochloride 150 mg/3mL · AuroMedics Pharma LLC