Drugplain

Family wellness .41 g/100g

BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE · OINTMENT · FRONT PHARMACEUTICAL PLC

10 Recalls on Record
Plain English

This topical ointment combines three antibiotics to help prevent infection in minor cuts, scrapes, and burns. You can buy it over the counter without a prescription.

Key Facts

Brand Name
Family wellness
Generic Name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
NDC Code (Product)
69571-003
Manufacturer
FRONT PHARMACEUTICAL PLC
Strength
.41 g/100g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M004
Marketing Start
02/22/2017

Recall History

10 Recalls on Record
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class III04/15/2014

P&L Developments, LLC

Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II11/22/2013

Faria Limited LLC dba Sheffield Pharmaceuticals

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class II01/03/2014

Dr. Reddy's Laboratories, Inc.

Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.

TerminatedVoluntary: Firm initiated
Class III09/03/2013

Novartis Consumer Health

Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue54,847 reports
nausea46,501 reports
off label use45,590 reports
drug ineffective44,899 reports
dyspnoea44,173 reports
diarrhoea42,149 reports
pain37,523 reports
headache37,507 reports
dizziness33,192 reports
vomiting31,864 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) relieves: acid indigestion heartburn

Dosage & Administration

DIRECTIONS adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor.

Warnings

WARNINGS .

Frequently Asked Questions

What is Family wellness used for?

This topical ointment combines three antibiotics to help prevent infection in minor cuts, scrapes, and burns. You can buy it over the counter without a prescription.

Is Family wellness a controlled substance?

Family wellness is not classified as a controlled substance by the DEA.

What is the generic name for Family wellness?

The generic name for Family wellness is BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE. There are 12 other brand versions of BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE.

What is the NDC code for Family wellness .41 g/100g?

The NDC (National Drug Code) for Family wellness .41 g/100g is 69571-003, listed by FRONT PHARMACEUTICAL PLC.