Drug 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: Beaumont Products, Inc. Kennesaw, GA 30144
D-1242-2020
Product summary
- Event
- Event 85274
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4790 tottles; 20,403 tubes
- Official record key
drug-enforcement:D-1242-2020
Official wording
Reason: Microbial contamination of non-sterile products: positive test for yeast and bacteria.
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
Distribution pattern: USA Nationwide
Derived failure modes
-
Microbial contamination
Microbial contamination