Class II · Moderate risk
Nexterone (amiodarone HCI)
CGMP Deviations
Amiodarone Hydrochloride Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Crystallization: Presence of visible particulate matter.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
Affected NDC
55150-0181-09
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 |
|---|---|---|---|---|
| Amiodarone Hydrochloride NDC 55150-0181 |
450 mg/9mL | Injection, Solution Intravenous |
AuroMedics Pharma LLC | Rx |
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-181-09
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0521-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 I · High risk
Nexterone (amiodarone HCl)
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
Other recalls by AuroMedics Pharma LLC
All 2019 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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