Class II · Moderate risk
Perrigo Bacitracin Ophthalmic Ointment
Lack of Assurance of Sterility
FDA Drug Recalls
360 recalls · Class II, newest first
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.
Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Aspirin Chewable Tablets
Presence of Foreign Substance: foreign material found in the bulk inventory.
Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Class II · Moderate risk
Sterile Water for Injection
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Class II · Moderate risk
Vitamin C (ascorbic acid)
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
Class II · Moderate risk
Relumins Advanced Glutathione
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Class II · Moderate risk
Saluta (reduced glutathione)
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Class II · Moderate risk
Tatiomax (reduced glutathione/hydrolyzed collagen)
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Laroscorbine Platinium
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.