Class II · Moderate risk
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials
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
Artesunate for Injection
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class II · Moderate risk
Testosterone Cypionate Testosterone Propionate
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility
Class II · Moderate risk
ceFAZolin 3 G in 0.9% Sodium Chloride
Lack of sterility assurance.
Class II · Moderate risk
ceFAZolin
Lack of sterility assurance.
Class II · Moderate risk
TheraTears Extra
Lack of Assurance of Sterility
Class II · Moderate risk
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral…
Lack of Assurance of Sterility
Class II · Moderate risk
Fulvestrant Injection 250 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Spironolactone Ophthalmic Solution 0.005 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Selinite 200mcg/Ml for Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Progesterone 100mg/Ml Mdv Oil Injection
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a/B6 15/50/100 5mg/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic 25/50/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 5000mcg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 12.5mg/Ml Mdv Inj Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 1000mcg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 10
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Folic Acid 10mg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Calcium Gluconate 10% Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Benzalkonium Chloride 0.013% Solution
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Acetylcysteine 2% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Acetylcysteine 10% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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