FDA recall D-0005-2015

Mckesson · Class II · drug

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2014-09-12
Report date: 2014-10-15
Termination date: 2017-04-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2015