Drugplain

Antimicrobial 665 mL/L

alcohol · LIQUID · Safetec of America, Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

Antimicrobial is a liquid containing alcohol at 665 mL/L, taken topical. Manufactured by Safetec of America, Inc..

Key Facts

Brand Name
Antimicrobial
Generic Name
alcohol
NDC Code (Product)
61010-3111
Manufacturer
Safetec of America, Inc.
Strength
665 mL/L
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
05/21/2012

Recall History

10 Recalls on Record
Class I03/10/2021

Sanit Technologies, LLC dba Durisan

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

TerminatedVoluntary: Firm initiated
Class I05/12/2021

Global Sanitizers LLC

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

OngoingVoluntary: Firm initiated
Class II05/12/2021

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

OngoingVoluntary: Firm initiated
Class II05/12/2021

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

OngoingVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class II08/15/2022

Ultra Chem Labs Corp

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

TerminatedN/A
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class II11/09/2018

Ecolab Inc

Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,928 reports
completed suicide5,410 reports
drug abuse5,270 reports
overdose1,899 reports
death1,597 reports
intentional overdose1,542 reports
suicide attempt1,341 reports
cardio-respiratory arrest1,340 reports
somnolence905 reports
drug dependence904 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Handwash to help decrease bacteria on the skin Recommended for repeated use

Dosage & Administration

Directions Wet hands Apply product and thoroughly cover hands with lather Rinse well and dry hands completely

Warnings

Warnings For external use only When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Antimicrobial used for?

Antimicrobial contains alcohol. It is a liquid taken topical. Consult your doctor for specific uses.

Is Antimicrobial a controlled substance?

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

What is the generic name for Antimicrobial?

The generic name for Antimicrobial is alcohol. There are 12 other brand versions of alcohol.

What is the NDC code for Antimicrobial 665 mL/L?

The NDC (National Drug Code) for Antimicrobial 665 mL/L is 61010-3111, listed by Safetec of America, Inc..