Drugplain

Bacitracin Zinc 500 [USP'U]/g

Bacitracin Zinc · OINTMENT · Chain Drug Marketing Association Inc.

10 Recalls on Record
Plain English

Bacitracin Zinc is a ointment containing bacitracin zinc at 500 [USP'U]/g, taken topical. Manufactured by Chain Drug Marketing Association Inc..

Key Facts

Brand Name
Bacitracin Zinc
Generic Name
Bacitracin Zinc
NDC Code (Product)
83324-040
Manufacturer
Chain Drug Marketing Association Inc.
Strength
500 [USP'U]/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M004
Marketing Start
06/11/2024

Recall History

10 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II10/13/2022

Akorn, Inc.

CGMP Deviations:

OngoingVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.

TerminatedVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective139 reports
dyspnoea99 reports
diarrhoea98 reports
nausea88 reports
dizziness84 reports
headache80 reports
rash80 reports
fatigue74 reports
erythema70 reports
pneumonia69 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses First aid to help prevent infection in minor: cuts scrapes burns

Dosage & Administration

Directions clean the affected area apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily. may be covered with a sterile bandage

Warnings

Warnings For external use only Allergy alert: do not use if you are allergic to any of the ingredients Do not use in or near the eyes on large areas of the body Consult a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer than 1 week Stop use and consult a doctor if condition persists or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction develops Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Frequently Asked Questions

What is Bacitracin Zinc used for?

Bacitracin Zinc contains Bacitracin Zinc. It is a ointment taken topical. Consult your doctor for specific uses.

Is Bacitracin Zinc a controlled substance?

Bacitracin Zinc is not classified as a controlled substance by the DEA.

What is the generic name for Bacitracin Zinc?

The generic name for Bacitracin Zinc is Bacitracin Zinc. There are 12 other brand versions of Bacitracin Zinc.

What is the NDC code for Bacitracin Zinc 500 [USP'U]/g?

The NDC (National Drug Code) for Bacitracin Zinc 500 [USP'U]/g is 83324-040, listed by Chain Drug Marketing Association Inc..