Altaire Pharmaceuticals CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL) recall — FDA D-0380-2020
Lack of Assurance of Sterility
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Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of foreign substance: Brown/black particles found during stability testing.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Lack of Assurance of Sterility
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Lack of Assurance of Sterility
CGMP Deviations: products were not manufactured under current good manufacturing practices.
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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