Drug recall D-0005-2015

Class II Terminated reported Oct 15, 2014

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.

Reason for recall

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.

Lots and codes

Lot #140502, Exp 10/31/2015

Recall details

Recalling firm
Mckesson, Jacksonville, FL
Quantity
10 vials
Distribution
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
Type
Voluntary: Firm initiated
Recall initiated
September 12, 2014
Terminated
April 17, 2017

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