Drugplain

Walgreens 4 mg/100mg

lidocaine · PATCH · WALGREENS

10 Recalls on RecordCurrently in Shortage
Plain English

Walgreens is a patch containing lidocaine at 4 mg/100mg, taken topical. Manufactured by WALGREENS.

Key Facts

Brand Name
Walgreens
Generic Name
lidocaine
NDC Code (Product)
0363-1002
Manufacturer
WALGREENS
Strength
4 mg/100mg
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Drug Class
Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
Marketing Start
08/16/2024

Recall History

10 Recalls on Record
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated
Class II08/23/2013

Walgreens Co

Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

TerminatedVoluntary: Firm initiated
Class III08/03/2018

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

TerminatedVoluntary: Firm initiated
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class II07/18/2012

LNK International, Inc.

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II04/16/2015

Tarmac Products, Inc.

Products failed the Antimicrobial Effectiveness Test

TerminatedVoluntary: Firm initiated
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use23,214 reports
drug ineffective22,556 reports
fatigue20,903 reports
nausea20,080 reports
pain17,431 reports
dyspnoea17,123 reports
diarrhoea16,028 reports
headache15,968 reports
vomiting15,093 reports
pyrexia13,661 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions -detach one suppository from the strip -remove wrapper before inserting into the rectum adults and children 12 years of age and older 1 suppository once daily children 6 to under 12 years 1/2 suppository once daily children under 6 years do not use

Dosage & Administration

Directions -detach one suppository from the strip -remove wrapper before inserting into the rectum adults and children 12 years of age and older 1 suppository once daily children 6 to under 12 years 1/2 suppository once daily children under 6 years do not use

Warnings

Warnings For rectal use only.

Frequently Asked Questions

What is Walgreens used for?

Walgreens contains lidocaine. It is a patch taken topical. Consult your doctor for specific uses.

Is Walgreens a controlled substance?

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

What is the generic name for Walgreens?

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

What is the NDC code for Walgreens 4 mg/100mg?

The NDC (National Drug Code) for Walgreens 4 mg/100mg is 0363-1002, listed by WALGREENS.