D-0005-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2014
- Initiation Date
- September 12, 2014
- Termination Date
- April 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 vials
Product Description
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 Pattern
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
Code Information
Lot #140502, Exp 10/31/2015