Amiodarone HCl Injection — Class II drug recall D-0005-2015
Terminated recall by Mckesson, reported 2014-10-15, distributed in MT, OR, WA. Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature
| Recall number | D-0005-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson, Jacksonville, FL, United States |
| Recall initiated | 2014-09-12 |
| Classified | 2014-10-03 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2017-04-17 |
| Distributed | MT, OR, WA |
| Quantity | 10 vials |
| Reason classes | labeling, temperature control |
| NDC | 67457-0153, 67457-0153-00, 67457-0153-03, 67457-0153-09, 67457-0153-18, 67457-0153-99 |
| Lot numbers | 140502 |
| Expiration dates | 2015-10-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0005-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.