Drug 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
D-0520-2020
Product summary
- Event
- Event 84240
- Status
- Terminated
- Classification
- Class III
- Quantity
- 28,810 vials
- Official record key
drug-enforcement:D-0520-2020
Official wording
Reason: Crystallization: Presence of visible particulate matter.
Code information: Lot# CAH180009, exp. date Feb 2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
particulate matter