CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
Amiodarone HCl Injection, 450 mg/ (50 mg per mL) Single-Use Vial recalled
Mckesson is recalling Amiodarone HCl Injection, 450 mg/ (50 mg per mL) Single-Use Vial, distributed in Montana, Oregon, Washington. The recall was initiated on 12 Sep 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0005-2015
- FDA event ID
- 69346
- Recalling firm
- Mckesson, Jacksonville, FL
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2014
- FDA classified
- 3 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Sep 2014 | Recall initiated by company | |
| 3 Oct 2014 | Classified by FDA | +21 days |
| 15 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
Questions about this recall
Why was it 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 lots are affected?
Lot #140502, Exp 10/31/2015
Where was it sold?
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalledGemcitabine | McKesson | Temperature Abuse | Nationwide |
| Drug | CLASS I | Udenyca, pegfilgrastim-cbqv injection recalled by McKessonUdenyca | McKesson | Temperature Abuse | Nationwide |
| Drug | CLASS II | Inflectra (infliximab-dyyb), For injection, 100mg per vial recalledInflectra | McKesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cabtreo (clindamycin phosphate, adapalene recalled by MckessonCabtreo | Mckesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
Other Amiodarone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | Mylan Institutional | Packaging Defects | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |