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Recall Observatory FDA recall evidence

Drug 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.

D-0100-2018

November 28, 2017

Class II

Product summary

Firm
EAI-JR286 INC
Event
Event 78595
Status
Terminated
Classification
Class II
Quantity
5,355 tubes
Official record key
drug-enforcement:D-0100-2018

Official wording

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

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

Distribution pattern: Nationwide in the USA and Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations