April 2024 FDA Recall Drug by Dercher Enterprises, Inc., Dba Gordon Laboratories
D-0495-2024 - cGMP Deviations
This Class II drug recall was voluntarily initiated by Dercher Enterprises, Inc., Dba Gordon Laboratories on April 12, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0495-2024
cGMP Deviations
04-12-2024
05-22-2024
5,247 glass jars
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dercher Enterprises, Inc., DBA Gordon Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
Batch or Lot Expiration Information
Lot# : F135, Exp. Date March 2025; F146, Exp. Date April , 2025; G103, Exp. Date January 2026; G194, Exp. Date September 2026
