November 2017 FDA Recall Drug by Eai-jr286 Inc
D-0100-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Eai-jr286 Inc on November 28, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0100-2018

Reason for Recall
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Initiated
11-28-2017
Reported
12-06-2017
Quantity
5,355 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78595
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.
EAI-JR286 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.
Nationwide in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2019
Product Description About Product Description
Full technical description of the product.
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.

Batch or Lot Expiration Information

Lot# : 609124, Exp 03/18 Manufacturing batches were mfg at Delta Laboratories under Batch Number 511103 11/16/2015 Batch Number 609124 09/21/2016