Nexterone — Class I drug recall D-0573-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-02-07, distributed nationwide. Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and
| Recall number | D-0573-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2017-11-10 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 35,628 single |
| Reason classes | specification failure |
| NDC | 43066-0150, 43066-0150-10, 43066-0360, 43066-0360-20 |
| Lot numbers | NC109123, NC109925 |
| Expiration dates | 2019-06-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0573-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.