Drug product
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
D-0521-2020
Product summary
- Event
- Event 84240
- Status
- Terminated
- Classification
- Class III
- Quantity
- 29,830 vials
- Official record key
drug-enforcement:D-0521-2020
Official wording
Reason: Crystallization: Presence of visible particulate matter.
Code information: Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
particulate matter