Class II · Moderate risk
Buprenorphine HCL 0.9 MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
BSS Plus/Lidocaine Opth 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Atropine sulfate 0.05%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Apomorphine HCL 2MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Albuterol (Pf/Sulfuric Acid/Dye Free)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
5-Fluorouracil 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Minoxidil 0.75%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Methylcobalamin 1MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin 25MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Chlorpheniramine/Hyoscyamine
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Dutasteride 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container…
Lack of sterility assurance: Bags have the potential to leak.
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
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility