Class II · Moderate risk Ongoing
Levofloxacin Ophthalmic Solution 0.5%
Reason CGMP Deviations:
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
GONAK Hypromellose Ophthalmic Demulcent Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Erythromycin Ophthalmic Ointment USP
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Erythromycin Ophthalmic Ointment USP 0.5%
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Cromolyn Sodium Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Betaxolol Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Artificial Tears Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Artificial Tears OINTMENT
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class II · Moderate risk Ongoing
Voriconazole Opth Solution 2% Sterile Soln
Reason 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 Ongoing
Vancomycin Intravitreal 1mg/0.1ml Solution
Reason 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 Ongoing
Talc
Reason 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 Ongoing
Serum Tears in Nsal 20% Opth Solution
Reason 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 Ongoing
Semaglutide Injection 5mg/Ml
Reason 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 Ongoing
Prostaglandin E1 Injection Solution 500mcg/Ml Solution
Reason 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 Ongoing
Pred Acetate / Gatifloxacin 1% / 0.5% Susp
Reason 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 Ongoing
Phentolamine 10mg/Ml Injection
Reason 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 Ongoing
Papaverine/Phentolamine/Prostaglandin Inj 150mg/5mg/10mcg/Vial Solution
Reason 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 Ongoing
Papaverine/Phentolamine/Prostaglandin Inj 150/5/50mcg / Vial Solution
Reason 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 Ongoing
Papaverine HCL Stock Solution 30mg/Ml Solution
Reason 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 Ongoing
Papaverine / Phentolamine Injection 150mg / 5mg / Vial Solution
Reason 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 Ongoing
Papaverine / Phentolamine / Prostaglandin Inj 90mg/3mg/29.4mcg/ Bottle Solution
Reason 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.