Recall: D-0005-2015

Class II - Potentially Harmful

Class IIClassification

2014-09-12Initiated

TerminatedStatus

MckessonFirm

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

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.

Distribution

McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.