Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
FDA Drug Recalls
46 recalls, newest first
Class II · Moderate risk
Gynazole-1
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk
Dr. Berne's MSM DROPS 5% Solution
CGMP Deviations
Class II · Moderate risk
Dr. Berne's Organic Castor Oil Eye Drops
CGMP Deviations
Class II · Moderate risk
Dr. Berne's MSM MIST 15% Solution
CGMP Deviations
Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
CGMP Deviations
Class II · Moderate risk
Dry Eye Relief Lubricant Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
Original Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Safe tussin PM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Pin-Away PYRENTAL PAMOATE
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Colic Calm
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Safe tussin DM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Pyrazinamide
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Ketotifen Fumarate 0.025 %
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Glimepiride Tablets USP
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Tadalafil Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Rosuvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Rosuvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.