Drugplain

Magnesium Chloride 200 mg/mL

magnesium chloride · INJECTION · Mylan Institutional LLC

10 Recalls on RecordCurrently in Shortage
Plain English

Magnesium Chloride is a injection containing magnesium chloride at 200 mg/mL, taken intravenous. Manufactured by Mylan Institutional LLC.

Key Facts

Brand Name
Magnesium Chloride
Generic Name
magnesium chloride
NDC Code (Product)
67457-134
Manufacturer
Mylan Institutional LLC
Strength
200 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Marketing Start
03/14/2013

Recall History

10 Recalls on Record
Class II07/30/2025

GenoGenix LLC

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II06/19/2019

RXQ Compounding LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II07/26/2013

Beacon Hill Medical Pharmacy, P.C.

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

TerminatedVoluntary: Firm initiated
Class II08/12/2019

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/21/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class II09/10/2015

Medistat RX L.L.C.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/19/2019

RXQ Compounding LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/09/2022

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

CompletedVoluntary: Firm initiated
Class II11/17/2016

Tri-Coast Pharmacy

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD52993_31, EXP: 5/17/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003526, EXP: 6/21/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W002766, EXP: 6/6/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedig

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue149 reports
nausea139 reports
off label use135 reports
diarrhoea134 reports
drug ineffective110 reports
pain110 reports
dyspnoea109 reports
asthenia104 reports
dizziness101 reports
headache99 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS As an electrolyte replenisher in magnesium deficiencies.

Dosage & Administration

DOSAGE AND ADMINISTRATION For intravenous infusion: 4 grams in 250 mL of 5% Dextrose Injection, at a rate not exceeding 3 mL per minute. Serum magnesium levels should serve as a guide to continued dosage.

Warnings

WARNING Do not use if a precipitate is present.

Contraindications

CONTRAINDICATIONS Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.

Adverse Reactions

ADVERSE REACTIONS Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately respiratory depression.

Frequently Asked Questions

What is Magnesium Chloride used for?

Magnesium Chloride contains magnesium chloride. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Magnesium Chloride a controlled substance?

Magnesium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Magnesium Chloride?

The generic name for Magnesium Chloride is magnesium chloride. There are 10 other brand versions of magnesium chloride.

What is the NDC code for Magnesium Chloride 200 mg/mL?

The NDC (National Drug Code) for Magnesium Chloride 200 mg/mL is 67457-134, listed by Mylan Institutional LLC.