Class II · Moderate risk
Lubricant Eye Drops Moisturizing
Lack of Assurance of Sterility
FDA Drug Recalls
164 recalls, newest first
Class II · Moderate risk
Puralube Ointment Petrolatum Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Bacitracin Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Polycin (bacitracin zinc and polymyxin B sulfate)
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Sterile Neo-Polycin HC
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Neo-Polycin neomycin and polymixin B sulfates and…
Lack of Assurance of Sterility
Class II · Moderate risk
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Drospirenone and Ethinyl Estradiol Tablets
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and HydrochlorothiazideTablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.