December 2017 FDA Recall Drug by Dlc Laboratories, Inc
D-0241-2018 - Microbial Contamination of Non-Sterile Products.

This Class II drug recall was voluntarily initiated by Dlc Laboratories, Inc on December 28, 2017 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0241-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products.
Initiated
12-28-2017
Reported
01-31-2018
Quantity
4,081 HDPE bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78841
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2019
Product Description About Product Description
Full technical description of the product.
Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307.

Batch or Lot Expiration Information

Batch# 4317; Exp. 02/19
Batch# 4393; Exp. 05/19
Batch# 4437; Exp. 07/19