Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz…
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
35 FDA recalls mention Avobenzone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Avobenzone.
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Reason Labeling: Label mix-up
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Reason cGMP Deviations; product does not comply with cGMP requirements
Reason cGMP Deviations; product does not comply with cGMP requirements
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