Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II · Moderate risk
Exparel
Sub Potent Drug: Out of Specification (OOS)
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class III · Low risk
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Nourishing Coconut invisible solid…
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
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.
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.