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Recall Observatory FDA recall evidence

Drug 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

D-1241-2020

March 19, 2020

Class II

Product summary

Firm
Filltech USA, LLC
Event
Event 85274
Status
Terminated
Classification
Class II
Quantity
4919 tottles
Official record key
drug-enforcement:D-1241-2020

Official wording

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

Code information: Lot #: 22J19, Exp 07/21

Distribution pattern: USA Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination