# FDA recall D-0005-2015

> **Mckesson** · Class II · drug recall initiated 2014-09-12.

## 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.

## Distribution

McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.

## Key facts

- **Recall number:** D-0005-2015
- **Recalling firm:** Mckesson
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-12
- **Report date:** 2014-10-15
- **Termination date:** 2017-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jacksonville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2015

## Citation

> AI Analytics. FDA recall D-0005-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0005-2015. Source: US FDA. Licensed CC0.

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