Drugplain

Glutathione 6 [hp_X]/mL

Glutathione · LIQUID · BioActive Nutritional, Inc.

10 Recalls on Record
Plain English

Glutathione is an antioxidant available over-the-counter as an oral liquid that your body produces naturally and uses to help protect cells from damage. It is commonly taken as a dietary supplement, though scientific evidence for many claimed benefits remains limited.

Key Facts

Brand Name
Glutathione
Generic Name
Glutathione
NDC Code (Product)
43857-0130
Manufacturer
BioActive Nutritional, Inc.
Strength
6 [hp_X]/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Marketing Start
02/28/2013

Recall History

10 Recalls on Record
Class II12/22/2022

Pharmacy Innovations

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

TerminatedVoluntary: Firm initiated
Class II05/13/2016

Medaus, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/19/2019

RXQ Compounding LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2015

Montana Compounding Pharmacy

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

TerminatedVoluntary: Firm initiated
Class II05/29/2013

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

OngoingVoluntary: Firm initiated
Class II05/17/2016

Well Care Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

TerminatedVoluntary: Firm initiated
Class II04/29/2014

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.

CompletedVoluntary: Firm initiated
Class II10/19/2015

Western Drug

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/17/2018

Guardian Pharmacy Services

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II01/15/2020

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use117 reports
nausea114 reports
hepatic function abnormal104 reports
fatigue101 reports
platelet count decreased96 reports
anaemia95 reports
headache85 reports
pyrexia84 reports
diarrhoea83 reports
pain79 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

none

Dosage & Administration

Direction of safe use 1. Rub the product between wetpalms until rich foam is formed.2. Apply the foam to face andbody, and massage gently tohelp care for the skin.3. Finally, rinse with clean water.

Warnings

Warning Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Frequently Asked Questions

What is Glutathione used for?

Glutathione is an antioxidant available over-the-counter as an oral liquid that your body produces naturally and uses to help protect cells from damage. It is commonly taken as a dietary supplement, though scientific evidence for many claimed benefits remains limited.

Is Glutathione a controlled substance?

Glutathione is not classified as a controlled substance by the DEA.

What is the generic name for Glutathione?

The generic name for Glutathione is Glutathione. There are 1 other brand versions of Glutathione.

What is the NDC code for Glutathione 6 [hp_X]/mL?

The NDC (National Drug Code) for Glutathione 6 [hp_X]/mL is 43857-0130, listed by BioActive Nutritional, Inc..

Product NDC

43857-0130

Package NDC

43857-0130-1

Other Glutathione Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)