Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Olopatadine HCL Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Ofloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Neomycin and Polymyxin B Sulfates
CGMP Deviations:
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 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.