Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 1908
Summary
The FDA issued a Class II for Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, by Dercher Enterprises, Inc., DBA Gordon Laboratories. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0495-2024
Action Date
2024-05-22
Status
Completed
Category
drug
Product Description
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
Lot/Code Info: Lot #: F135, Exp. Date March 2025; F146, Exp. Date April , 2025; G103, Exp. Date January 2026; G194, Exp. Date September 2026
Quantity Affected: 5,247 glass jars
Reason for Recall
cGMP Deviations
Distribution
Product was distributed nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-12
Company
Upper Darby, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 37 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dercher Enterprises, Inc., DBA Gordon Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dercher Enterprises, Inc., DBA Gordon Laboratories have FDA actions?
This is the only FDA action we have on record for Dercher Enterprises, Inc., DBA Gordon Laboratories in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0495-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22