Class III · Low risk
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Mirtazapine Tablets
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I · High risk
Mirtazapine Tablets
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class II · Moderate risk
Gabapentin Capsules
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class II · Moderate risk
0.9% Sodium Chloride Irrigation USP 5000 mL bags
Lack of Assurance of Sterility: Product has the potential to leak.
Class III · Low risk
Timolol Maleate Sterile Opthalmic Solution
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Class III · Low risk
Timolol Maleate USP
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Class III · Low risk
Colostat
Labeling mix-up - Indications on product label are incorrect.
Class II · Moderate risk
MYORISAN (isotretinoin capsules, USP)
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class II · Moderate risk
Yeast Arrest
cGMP violations
Class II · Moderate risk
AVKARE Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
AVKARE Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Oral Solution
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Class I · High risk
Silver Bullet
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class II · Moderate risk
Fluphenazine Decanoate Injection USP 125mg/5mL
Discoloration; Hazy solution found in one vial instead of a clear solution.
Class II · Moderate risk
fentaNYL 550 mcg/55 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 1000 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 1500 mcg/30 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 2500 mcg/50 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 800 mcg/200 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 1250 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 1000 mcg/20 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules