FDAFDA · Food and drugs·Recall number D-0005-2015
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.
Published October 15, 2014 · Recall initiated: September 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- Mckesson
- Distributor
- McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
- Lot
- Lot #140502, Exp 10/31/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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