Class II · Moderate risk
Hydromorphone HCl 10 mg
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
fentanyl citrate
Lack of Assurance of Sterility.
Class II · Moderate risk
fentaNYL citrate 1000 mcg
Lack of Assurance of Sterility.
Class II · Moderate risk
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride
Lack of Assurance of Sterility.
Class II · Moderate risk
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag
Lack of Assurance of Sterility.
Class II · Moderate risk
methylPREDNIsolone ACETATE
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class II · Moderate risk
Symbio Muc Eye
Lack of Assurance of Sterility
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Alcohol Prep Pads
Lack of Assurance of Sterility and cGMP Deviations
Class II · Moderate risk
Sterile Water for Injection
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Levophed (norepinephrine bitartrate)
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk
HYDROmorphone HCl Injection
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk
All Sterile Products within expiry
Lack of Assurance of Sterility .
Class II · Moderate risk
BevaDex (bevacizumab)
Lack of Assurance of Sterility.
Class II · Moderate risk
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes
Lack of Assurance of Sterility.
Class II · Moderate risk
Fluorescein Sodium
Lack of Assurance of Sterility.
Class II · Moderate risk
Sodium Bicarbonate 8.4%
Lack of Assurance of Sterility.
Class II · Moderate risk
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution
Lack of Assurance of Sterility.
Class II · Moderate risk
Lidocaine Ophthalmic Gel 3.5%
Lack of Assurance of Sterility.
Class II · Moderate risk
Mic 25/50/50
Lack of Assurance of Sterility.
Class II · Moderate risk
L-Glutamine 100mg
Lack of Assurance of Sterility.
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