Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Exparel
Reason Sub Potent Drug: Out of Specification (OOS)
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class III · Low risk Terminated
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant &…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48hr Confidence Regular Original Solid Anti-Perspirant &…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48hr Confidence Nourishing Coconut invisible solid…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class I · High risk Terminated
Mirtazapine Tablets
Reason 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 Terminated
Mirtazapine Tablets
Reason 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 Terminated
Gabapentin Capsules
Reason Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation USP 5000 mL bags
Reason Lack of Assurance of Sterility: Product has the potential to leak.
Class III · Low risk Terminated
Timolol Maleate Sterile Opthalmic Solution
Reason 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 Terminated
Timolol Maleate USP
Reason 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 Terminated
Colostat
Reason Labeling mix-up - Indications on product label are incorrect.
Class II · Moderate risk Terminated
Myorisan
Reason 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 Terminated
Clobetasol Propionate Foam
Reason Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk Terminated
Clobetasol Propionate Foam
Reason Defective delivery system; product is not foaming or is coming out as liquid.
Class II · Moderate risk Terminated
Yeast Arrest
Reason cGMP violations
Class II · Moderate risk Terminated
AVKARE Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
AVKARE Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine Oral Solution
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Class I · High risk Terminated
Silver Bullet
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class II · Moderate risk Terminated
Fluphenazine Decanoate Injection USP 125mg/5mL
Reason Discoloration; Hazy solution found in one vial instead of a clear solution.
Class II · Moderate risk Terminated
fentaNYL 550 mcg/55 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules