Class II · Moderate risk
Neomycin and Polymyxin B Sulfates
CGMP Deviations:
FDA Drug Recalls
241 recalls, newest first
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
CGMP Deviations:
Class II · Moderate risk
Levofloxacin Ophthalmic Solution 0.5%
CGMP Deviations:
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
GONAK Hypromellose Ophthalmic Demulcent Solution
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP 0.5%
CGMP Deviations:
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Betaxolol Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Artificial Tears Solution
CGMP Deviations:
Class II · Moderate risk
Artificial Tears OINTMENT
CGMP Deviations:
Class II · Moderate risk
Class III · Low risk
oxyTOCIN 30 Units/500 mL
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
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
Triamcinolone Acetonide cream
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Triamcinolone Acetonide Cream USP
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations;
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg per suppository
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection