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Tavaborole Topical Solution (Viona) - Discoloration (2025)

Discoloration

Class IIModerate

FDAAug 12, 2025Nationwide• VIONA PHARMACEUTICALS INC

Graham Cracker Meal (Bakers Authority) – Undeclared allergens (2025)

Undeclared Allergen

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

Class IIModerate

FDAAug 12, 2025CA, CT, GA +14 more• Bakers Authority LLC

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Tavaborole Topical Solution (Viona) - Discoloration (2025)

Graham Cracker Meal (Bakers Authority) – Undeclared allergens (2025)

FLEX Monoclonal Mouse Antibody (Agilent) – weak staining (2025)

Atellica CH Protein Test (Siemens) – false result risk (2025)

Lisdexamfetamine Capsules (Lannett) - Label Mix-up (2025)

Merge Hemo Software (Merge Healthcare) – patient data issue (2025)

VACUETTE Coagulation Tube (Greiner) – label misplacement (2025)

Sterile Medline Convenience Kits (Unknown) – sterilization failure (2025)

RayStation Software (RaySearch) – UID uniqueness (2025)

Argus PB-3000 Monitor (Schiller) – measurement error (2025)

Continu-Flo Solution Set (Baxter) – customer reports (2025)

IntelliSpace Cardiovascular (Philips) – outdated info (2025)

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

Theophylline Tablets (Glenmark) - Failed Dissolution (2025)

FloPatch FP120 (Flosonics) – expiry date error (2025)

Carvedilol Tablets 3.125mg (Glenmark) - Nitrosamine Impurity (2025)

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Impurity (2025)

Frozen Oysters (Wang Globalnet) – Norovirus contamination (2025)

Reduced Sodium Roast Beef Rub (QST Ingredients) – Metal fragment risk (2025)

Cajun Seasoning (QST Ingredients) – Metal fragment risk (2025)