Amiodarone Hydrochloride Injection, Solution
FDA Recall NDC 67457-153
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Amiodarone Hydrochloride (NDC 67457-153). A significant event, classified as Class I, was initiated on Aug 17, 2020 by Mylan Institutional Llc. The reported reason for this action was: "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."
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 I Terminated
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.
Aug 17, 2020
Sep 09, 2020
13,682 cartons
Recall Profile & Regulatory Data
Event ID
86247
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Mylan Institutional LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 28, 2022
Product Description
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
Batch or Lot Expiration Information
Lot# : 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
Affected Packages Involved in this Recall
67457-153-00Product
67457-153-03Product
67457-153-99Product
67457-153-09Product
67457-153-18Product
Class II Terminated
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Sep 12, 2014
Oct 15, 2014
10 vials
Recall Profile & Regulatory Data
Event ID
69346
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
Termination Date
Apr 17, 2017
Product Description
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.
Batch or Lot Expiration Information
Lot# 140502, Exp 10/31/2015
Affected Packages Involved in this Recall
67457-153-00Product
67457-153-03Product
67457-153-99Product
67457-153-09Product
67457-153-18Product
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.
