Class II · Moderate risk
LX Bioboost Plus
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
LL Bioboost Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
CJC-1295 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Lubricant Eye Drops Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Artificial Tears Ophthalmic Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk
FentaNYL 500mcg
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Ketamine HCl 50mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
dexmedeTOMIDine HCl PF
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 100mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
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