The Recall Desk

FDA (Drugs) recall action 85274

Filltech USA, LLC recalled 2 products on 2020-04-22

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-04-22
Critical
0
Units
4,919

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2020-04-22

    Dermatone Sunscreen Recalled for Microbial Contamination

    Filltech USA is recalling Dermatone Sunscreen Lotion due to positive tests for yeast and bacteria.

    Product
    Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2020-04-22

    Dermatone Sunscreen Recalled for Microbial Contamination

    Filltech USA is recalling Dermatone Sunscreen Lotion SPF 50 due to positive tests for yeast and bacteria.

    Product
    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…
    Category
    Distribution
    0 states