D-0573-2018 Class I Terminated
FDA drug recall D-0573-2018 was initiated by Baxter Healthcare Corporation on Nov 10, 2017 and is designated Class I. 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 The recall status is terminated (terminated Aug 29, 2018). Affected quantity: 35,628 single-dose containers.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 7, 2018
- Initiation Date
- Nov 10, 2017
- Termination Date
- Aug 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,628 single-dose containers
Product description
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
Distribution pattern
Nationwide within USA and Puerto Rico
Code information
Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0573-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026