Drug recall D-0573-2018
Product
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Reason for recall
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
Lots and codes
Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- 35,628 single-dose containers
- Distribution
- Nationwide within USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 10, 2017
- Terminated
- August 29, 2018
Related products
- Nexterone – drug information
- NDC 43066-150 Nexterone · Amiodarone Hydrochloride 1.5 mg/mL · Baxter Healthcare Corporation
- NDC 43066-360 Nexterone · Amiodarone Hydrochloride 1.8 mg/mL · Baxter Healthcare Corporation