June 2018 FDA Recall Drug by Eb5 Corporation
D-0908-2018 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Eb5 Corporation on June 22, 2018 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Distributed Nation Wide in the USA. and the recall is currently terminated.

Recall Number: D-0908-2018

Reason for Recall
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Initiated
06-22-2018
Reported
07-11-2018
Quantity
4,632 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80359
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.
Eb5 Corporation
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.
Distributed Nation Wide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-22-2023
Product Description About Product Description
Full technical description of the product.
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9

Batch or Lot Expiration Information

Batch# Batch B4276A EXP 03/2019