13 FDA recalls mention Royal. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Royal.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Reason Microbial contamination
Reason Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Lack of Assurance of Sterility
Reason Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Reason Non-Sterility: The firm's contract testing laboratory found sterility failures.
Reason Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Reason Non-Sterility
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