Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Reported: February 7, 2018 Initiated: November 10, 2017 #D-0573-2018
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
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 35,628 single-dose containers
- Distribution
- Nationwide within USA and Puerto Rico
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10. Recalled by Baxter Healthcare Corporation. Units affected: 35,628 single-dose containers.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Critical. Recall number: D-0573-2018.
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