Class II · Moderate risk
HCG Reconstitued 50
Lack of Assurance of Sterility
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
HCG Lyophilized 5000 IU Injectable Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Glycerin 72%
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200 mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Glutamine 10 mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Epi-Shugarcaine Kit Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Dexpanthenol Injection
Lack of Assurance of Sterility
Class III · Low risk
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate 10%
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate1% Eyewash 10 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate 1% Eyewash Oph. Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg)
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bacteriostatic Water for Injection 10 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Beta-complex B-1
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid 500 mg/mL Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine Injections 100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Acetylcysteine Injection 10 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Folic Acid injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Enanthate/Cypionate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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