D-0100-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2017
- Initiation Date
- November 28, 2017
- Termination Date
- August 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,355 tubes
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.
Distribution Pattern
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