Class II · Moderate risk
Nexterone (amiodarone HCI)
CGMP Deviations
Nexterone (amiodarone HCl) (Amiodarone Hydrochloride)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Affected NDC
43066-0150-10
Compare with the code on your package — it is the most precise check available.
Drug: Amiodarone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nexterone amiodarone hydrochloride NDC 43066-0150 |
1.5 mg/mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 43066-150-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0573-2018 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Amiodarone recalls
See all
Class I · High risk
Amiodarone Hydrochloride Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Other recalls by Baxter Healthcare Corporation
All 2017 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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