Drug product
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
D-0573-2018
Product summary
- Event
- Event 78531
- Status
- Terminated
- Classification
- Class I
- Quantity
- 35,628 single-dose containers
- Official record key
drug-enforcement:D-0573-2018
Official wording
Reason: Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Code information: Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
Distribution pattern: Nationwide within USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter