FDAClass IIDecember 6, 2017

Vertra Elemental Resistance recall: CGMP Deviations

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.

Why was Vertra Elemental Resistance recalled?

CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
EAI-JR286 INC
Quantity
5,355 tubes
Distribution
Nationwide in the USA and Puerto Rico.
Recall date
December 6, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls