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Lack of Processing Controls.
Allergen not listed in the Contains statement: Sesame
Individual consumer size Wasabi mini pack label does not declare allergen ingredient Yellow 5.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations
Subpotent Drug
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Dissolution Specifications.
Undeclared allergens (Peanut) due to mispackaging