FDA Recall Amiodarone Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on August 17th, 2020 and classified as a Class I recall due to 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 recall is currently terminated, and the associated recall number is recall number is D-1575-2020. It pertains to Amiodarone Hydrochloride identified by 67457-153 as of 12-28-2022 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1575-2020 | 08-17-2020 | 09-09-2020 | 13,682 cartons | 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. | 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. | Terminated |
| D-0005-2015 | 09-12-2014 | 10-15-2014 | 10 vials | 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. | 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. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
