Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Budesonide Inhalation Suspension 0.25mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Lisinopril 10 mg tablets
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class III · Low risk
Phytonadione Injectable Emulsion USP
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class I · High risk
Antica Farmacista Hand Sanitizer Ocean Citron
Chemical Contamination: product found to contain benzene
Class II · Moderate risk
Sanitizing Hand Spray 80%
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Triamcinolone Acetonide cream
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Synergy Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class III · Low risk
Antibacterial Foaming Wash with Hydria Moisturizing Formula
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Class II · Moderate risk
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QUAD-MIX 30/2/60/0.15 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 50/2.5/25 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/60 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/10 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Prop
Lack of Assurance of Sterility