Drugplain

Antiseptic Hand Sanitizer 620 mg/g

ALCOHOL · LIQUID · Hubei Changjian Medical Products Co., Ltd.

8 Recalls on RecordCurrently in Shortage
Plain English

Antiseptic Hand Sanitizer is a liquid containing alcohol at 620 mg/g, taken topical. Manufactured by Hubei Changjian Medical Products Co., Ltd..

Key Facts

Brand Name
Antiseptic Hand Sanitizer
Generic Name
ALCOHOL
NDC Code (Product)
82996-005
Manufacturer
Hubei Changjian Medical Products Co., Ltd.
Strength
620 mg/g
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
11/01/2022

Recall History

8 Recalls on Record
Class I08/14/2020

Grupo Asimex de Mexico SA de CV

Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.

TerminatedVoluntary: Firm initiated
Class II12/15/2022

Frenda Corporation

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class I07/27/2020

Broncolin, S.A. de C.V.

Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.

TerminatedVoluntary: Firm initiated
Class II07/31/2020

Laboratorios Jaloma S.A. de C.V.

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II07/27/2020

Broncolin, S.A. de C.V.

CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.

TerminatedVoluntary: Firm initiated
Class II08/18/2020

Nanomateriales Sa De Cv

GMP Deviations: Potential to contain 1-propanol.

TerminatedVoluntary: Firm initiated
Class II08/18/2020

Nanomateriales Sa De Cv

GMP Deviations: Potential to contain 1-propanol.

TerminatedVoluntary: Firm initiated
Class II08/14/2020

Grupo Asimex de Mexico SA de CV

CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Dosage & Administration

Directions Wet hands thoroughly with product and allow to dry without wiping.

Warnings

Warnings Flammable, keep away from fire or flame For external use only. Do not use in the eyes. Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Antiseptic Hand Sanitizer used for?

Antiseptic Hand Sanitizer contains ALCOHOL. It is a liquid taken topical. Consult your doctor for specific uses.

Is Antiseptic Hand Sanitizer a controlled substance?

Antiseptic Hand Sanitizer is not classified as a controlled substance by the DEA.

What is the generic name for Antiseptic Hand Sanitizer?

The generic name for Antiseptic Hand Sanitizer is ALCOHOL. There are 12 other brand versions of ALCOHOL.

What is the NDC code for Antiseptic Hand Sanitizer 620 mg/g?

The NDC (National Drug Code) for Antiseptic Hand Sanitizer 620 mg/g is 82996-005, listed by Hubei Changjian Medical Products Co., Ltd..