Drug Enforcement D-0495-2024

cGMP Deviations

Status

Completed

Classification

Class II

Report Date

May 22, 2024

Termination Date

Product Information

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
Product quantity
5,247 glass jars
Reason for recall
cGMP Deviations
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Product was distributed nationwide within the United States

Location & Firm

Recalling firm
Dercher Enterprises, Inc., DBA Gordon Laboratories
Address
6801 Ludlow St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0495-2024
Event ID
94355
Recall initiation date
April 12, 2024
Center classification date
May 13, 2024
Code info
Lot #: F135, Exp. Date March 2025; F146, Exp. Date April , 2025; G103, Exp. Date January 2026; G194, Exp. Date September 2026
More code info