36 FDA recalls mention Octisalate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Octisalate.
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Reason Labeling: Label mix-up
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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