Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zin...
FDA Recall #D-0100-2018 — Class II — November 28, 2017
Product Description
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.
Reason for Recall
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Recalling Firm
EAI-JR286 INC — Torrance, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,355 tubes
Distribution
Nationwide in the USA and Puerto Rico.
Code 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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated