Rohto Cooling Eye Drops ALL-IN-ONE recall — FDA D-0715-2026
Lack of Assurance of Sterility
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Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12…
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be…
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Subpotent Drug
Presence of Particulate Matter: Hair was found in product
Presence of Particulate Matter: Hair was found in products
Lack of Assurance of Sterility
Subpotent Drug
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Lack of Assurance of Sterility
Presence of Particulate Matter: Hair was found in products
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12…
Lack of Assurance of Sterility
Presence of Particulate Matter: Hair was found in products
Lack of Assurance of Sterility
Subpotent Drug
Presence of Particulate Matter: Hair was found in products
Subpotent Drug
Lack of Assurance of Sterility
Subpotent Drug
Lack of Assurance of Sterility
Undeclared Allergen (Fish)
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