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Product may be contaminated with Cesium-137 (Cs-137).
Temperature Abuse
Undeclared wheat allergen.
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea salt
Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flax
Potential contamination with foreign objects.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Discoloration
Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Undeclared eggs
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Oyster product potentially contaminated with Norovirus
Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.