Class II · Moderate risk
MITOMYCIN INJECTION 0.375 mg/mL SYR
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.
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
METHYLCOBALAMIN PF 1 ML Injection Solution 5
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
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension
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
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 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
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% 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
LAURETH-9 INJ 2% 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
GLYCERIN OPHTHALMIC DROPS 98.5% 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
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles
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
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe
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
CEFTAZIDIME INTRAVITREAL 2.25MG/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
Brilliant Blue G
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
Autologus Tears Serum Soln Full Strength
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
ACETYLCYSTEINE OPTH 5% 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
ACETYLCYSTEINE OPTH 10% 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
Arformoterol Tartrate Inhalation Solution
Lack of Assurance of Sterility: environmental monitoring failure.
Class II · Moderate risk
Budesonide Inhalation Suspension 0.25mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QUAD-MIX 30/2/60/0.15 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 50/2.5/25 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/60 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/40 Injectable
Lack of Assurance of Sterility