CLASS II Drug recall · Reported 3 Jan 2018 · FDA Enforcement Report

Amiodarone 900 mg in dextrose 5%, Concentration: 1.8 mg/mL recalled

SSM Health Care St. Louis is recalling Amiodarone 900 mg in dextrose 5%, Concentration: 1.8 mg/mL, This is a compounded, distributed in Missouri. The recall was initiated on 10 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 170711-005, 10/09/2017

Quantity recalledN/A

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-0137-2018
FDA event ID: 78678
Recalling firm: SSM Health Care St. Louis, Fenton, MO
Classification: Class II
Status: Terminated
Recall initiated: 10 Aug 2017
FDA classified: 28 Dec 2017
Reported: 3 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

10 Aug 2017	Recall initiated by company
28 Dec 2017	Classified by FDA	+140 days
3 Jan 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01

Where it was distributed

SSM Health entities in the state of MO only

Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot: 170711-005, 10/09/2017

Where was it sold?

SSM Health entities in the state of MO only

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.

Other products in this recall event

9 other products · FDA event 78678

This product is part of a recall event; the main page for the event is Norepinephrine 8 mg in dextrose 5% IV, Concentration recalled.

Reported	Class	Recall	Company	Reason	Where
3 Jan 2018	CLASS II	Norepinephrine 8 mg in dextrose 5% IV, Concentration recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Morphine 50 mg in 0.9% Sodium Chloride PCA Cartridge recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Fentanyl 10 mcg in 0.9% Sodium Chloride Vial, Concentration recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Neostigmine Methylsulfate 5 mg/ Syringe, Concentration recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Succinylcholine chloride 100 mg in syringe, Concentration recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Phenylephrine 1000 mcg in 0.9% Sodium Chloride syringe recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Oxytocin in 0.9% Sodium Chloride IV recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	Fentanyl 2 mcg/mL and ropivacaine recalled by SSM Health Care St. Louis	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018	CLASS II	HYDROmorphone 10 mg in 0.9% Sodium Chloride PCA Cartridge recalled	SSM Health Care St. Louis	Sterility	MO

More recalls from SSM Health Care St. Louis

All 14

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Drug	CLASS II	FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride Vial recalled	SSM Health Care St. Louis	Sterility	MO
10 Apr 2024Drug	CLASS II	Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled	SSM Health Care St. Louis	Sterility	MO
7 Jun 2023Drug	CLASS II	HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge syringe (0.2 mg/mL) recalled	SSM Health Care St. Louis	Manufacturing (CGMP) Deviations	MO
20 Oct 2021Drug	CLASS II	Potassium Chloride 40 mEq in 0.9% Sodium Chloride NS recalled	SSM Health Care St. Louis	Sterility	MO
3 Jan 2018Drug	CLASS II	HYDROmorphone 10 mg in 0.9% Sodium Chloride PCA Cartridge recalled	SSM Health Care St. Louis	Sterility	MO

Other Amiodarone recalls

All 8

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2020Drug	CLASS I	Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride	Mylan Institutional	Packaging Defects	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide