FDA Drug recall 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, I…
- FDA Drug
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, I… by Mckesson, citing temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distrib….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0005-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-12 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mckesson |
| Distribution | MT, OR, WA |
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.
Identifiers
| ndc | 67457-153-00 |
|---|---|
| ndc | 67457-153-03 |
| ndc | 67457-153-99 |
| ndc | 67457-153-09 |
| ndc | 67457-153-18 |
| code_info | Lot #140502, Exp 10/31/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0005-2015%22
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