Amiodarone Hydrochloride Injection, Solution
FDA Recall NDC 55150-182
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Amiodarone Hydrochloride (NDC 55150-182). A significant event, classified as Class III, was initiated on Nov 11, 2019 by Auromedics Pharma Llc. The reported reason for this action was: "Crystallization: Presence of visible particulate matter."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Crystallization: Presence of visible particulate matter.
Nov 11, 2019
Dec 04, 2019
29,830 vials
Recall Profile & Regulatory Data
Event ID
84240
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Apr 01, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
Affected Packages Involved in this Recall
55150-180-03Product
55150-181-09Product
55150-182-18Product
Class III Terminated
Crystallization: Presence of visible particulate matter.
Nov 11, 2019
Dec 04, 2019
28,810 vials
Recall Profile & Regulatory Data
Event ID
84240
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Apr 01, 2021
Product Description
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03
Batch or Lot Expiration Information
Lot# CAH180009, exp. date Feb 2020
Affected Packages Involved in this Recall
55150-180-03Product
55150-181-09Product
55150-182-18Product
Class III Terminated
Crystallization: Presence of visible particulate matter.
Nov 11, 2019
Dec 04, 2019
138,720 vials
Recall Profile & Regulatory Data
Event ID
84240
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Apr 01, 2021
Product Description
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
Batch or Lot Expiration Information
Lot# : CAH180013, CAH180014, exp. date Jul 2020
Affected Packages Involved in this Recall
55150-180-03Product
55150-181-09Product
55150-182-18Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
