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Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, ...

FDA Recall #D-1242-2020 — Class II — March 19, 2020

Recall #D-1242-2020 Date: March 19, 2020 Classification: Class II Status: Terminated

Product Description

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

Reason for Recall

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

Recalling Firm

Filltech USA, LLC — Rockwell, NC

Classification

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

Product Type

Drugs

Product Quantity

4790 tottles; 20,403 tubes

Distribution

USA Nationwide

Code Information

Lot #: a) 05J19, Exp 07/21; b) 05J19, Exp 07/21, 43L19, Exp 09/21; c) 43L19 Exp 09/21, 44L19 Exp 09/21

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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