Drug product
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
D-0522-2020
Product summary
- Event
- Event 84240
- Status
- Terminated
- Classification
- Class III
- Quantity
- 138,720 vials
- Official record key
drug-enforcement:D-0522-2020
Official wording
Reason: Crystallization: Presence of visible particulate matter.
Code information: Lot#: CAH180013, CAH180014, exp. date Jul 2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
particulate matter