September 2014 FDA Recall Amiodarone Hydrochloride by Mckesson
D-0005-2015 - Temperature Abuse
This Class II drug recall was voluntarily initiated by Mckesson on September 12, 2014 for the product Amiodarone Hydrochloride. The FDA reported the reason for recall as temperature abuse. The product was distributed in McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT. and the recall is currently terminated.
Recall Number: D-0005-2015
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.
09-12-2014
10-15-2014
10 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mckesson
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
04-17-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
