Class II · Moderate risk
Glycolic Acid 15% Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
Fluocinonide 0.05% Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Fluororacil 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Erythromycin 2% in Cerave Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clobetasol 0.05% in Olea Base
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clindamycin 1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Bleaching Cream 0.1% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Bl 20%/4% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Benzoyl Peroxide 5% Clindamycin 1.2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Adapalene 0.1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Bicarbonate 10%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
MINOXADIL all strength including 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
5-Fluorouracil in Vanicream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HCG and HCG with resveratrol Human Chorionic Gonadotropin in…
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Human Chorionic Gonadotropin
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
METRONIDazole Injection
Lack of Sterility Assurance: customer report of leaking bag
Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Lack of Sterility Assurance
Class II · Moderate risk
AMGEN Kyprolis
Lack of Assurance of Sterility: Potential cracks in glass vials
Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class II · Moderate risk
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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