January 2021 FDA Recall Drug by Dlc Laboratories, Inc
D-0257-2021 - Labeling

This Class II drug recall was voluntarily initiated by Dlc Laboratories, Inc on January 6, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0257-2021

Reason for Recall
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Initiated
01-06-2021
Reported
02-24-2021
Quantity
86,297 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87257
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
DLC Laboratories, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide and to the following foreign countries: Canada, Cambodia, Germany, and United Kingdom.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2022
Product Description About Product Description
Full technical description of the product.
Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426

Batch or Lot Expiration Information

Lot# 5084, Exp 05/23; 5130, Exp 07/23; 5132, Exp 07/23; 5160, Exp 08/23.