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Subpotent Drug
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
contaminated with Bacillus cereus and may be spoiled
Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)
Lack of Assurance of Sterility
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Undeclared wheat allergens
Undeclared sesame and wheat allergens