FDA Drug recall D-0573-2018
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC…
- FDA Drug
- Class I
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class I recall of Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC… by Baxter Healthcare, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0573-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-11-10 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
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
Identifiers
| ndc | 43066-150-10 |
|---|---|
| ndc | 43066-360-20 |
| code_info | Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0573-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.