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Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis B...

FDA Recall #D-0813-2018 — Class II — May 4, 2018

Recall #D-0813-2018 Date: May 4, 2018 Classification: Class II Status: Terminated

Product Description

Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.

Reason for Recall

GMP Deviations

Recalling Firm

Milbar Laboratories, Inc. — East Haven, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

4,815 tubes

Distribution

Within the United States and Puerto Rico

Code Information

Lot #: KU455-4, Exp.10/30/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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