Drugplain

Bacitracin 500 [USP'U]/g

Bacitracin · OINTMENT · Bryant Ranch Prepack

10 Recalls on Record
Plain English

Bacitracin is a ointment containing bacitracin at 500 [USP'U]/g, taken topical. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Bacitracin
Generic Name
Bacitracin
NDC Code (Product)
72162-2280
Manufacturer
Bryant Ranch Prepack
Strength
500 [USP'U]/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M004
Marketing Start
06/20/2011

Recall History

10 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II06/02/2015

The Compounding Pharmacy of America

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

TerminatedVoluntary: Firm initiated
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 II04/02/2019

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class III05/28/2013

Faria Limited LLC dba Sheffield Pharmaceuticals

Failed Stability Specifications: Unable to meet shelf life expiry.

TerminatedVoluntary: 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

Side Effects Reported to FDA

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

drug hypersensitivity379 reports
drug ineffective238 reports
pain214 reports
nausea211 reports
diarrhoea200 reports
dyspnoea193 reports
rash185 reports
fatigue179 reports
off label use151 reports
pyrexia151 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 of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage

Warnings

Warnings For external use only Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Frequently Asked Questions

What is Bacitracin used for?

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

Is Bacitracin a controlled substance?

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

What is the generic name for Bacitracin?

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

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

The NDC (National Drug Code) for Bacitracin 500 [USP'U]/g is 72162-2280, listed by Bryant Ranch Prepack.