FDA Recall D-0573-2018
Baxter Healthcare Corporation · Deerfield, IL
Class I — life-threatening Terminated 292 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0573-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within USA and Puerto Rico
- Recall initiated
- 2017-11-10
- Classified by FDA Center
- 2018-03-01
- FDA published
- 2018-02-07
- Terminated
- 2018-08-29
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- NEXTERONE
- Generic name(s)
- AMIODARONE HYDROCHLORIDE
- Manufacturer(s)
- Baxter Healthcare Company
- NDC(s)
43066-150, 43066-360- Route(s)
- INTRAVENOUS