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.
Reported: October 15, 2014 Initiated: September 12, 2014 #D-0005-2015
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.
Details
- Recalling Firm
- Mckesson
- Units Affected
- 10 vials
- Distribution
- McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
- Location
- Jacksonville, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mckesson. Units affected: 10 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 15, 2014. Severity: Moderate. Recall number: D-0005-2015.
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