Class II · Moderate risk
GONAK Hypromellose Ophthalmic Demulcent Solution
CGMP Deviations:
FDA Drug Recalls
268 recalls, newest first
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 II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class II · Moderate risk
Voriconazole Opth Solution 2% Sterile Soln
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Vancomycin Intravitreal 1mg/0.1ml Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Talc
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Serum Tears in Nsal 20% Opth Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Semaglutide Injection 5mg/Ml
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Prostaglandin E1 Injection Solution 500mcg/Ml Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Pred Acetate / Gatifloxacin 1% / 0.5% Susp
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Phentolamine 10mg/Ml Injection
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin Inj 150mg/5mg/10mcg/Vial Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin Inj 150/5/50mcg / Vial Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine HCL Stock Solution 30mg/Ml Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine / Phentolamine Injection 150mg / 5mg / Vial Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine / Phentolamine / Prostaglandin Inj 90mg/3mg/29.4mcg/ Bottle Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine / Phentolamine / Prostaglandin Inj 75mg/2.5mg/50mcg/ Bottle Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Papaverine / Phentolamine / Prostaglandin Inj 150mg/10mg/100mcg/ Bottle Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.