Class II · Moderate risk Completed
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS…
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Completed
CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g), Distributed by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84…
Reason Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…