Class II · Moderate risk
fentanyl citrate
Lack of Assurance of Sterility.
FDA Drug Recalls
6,161 recalls · Class II, newest first
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 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.
Class II · Moderate risk
Magnesium Chloride 200mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Methylcobalamin 10mg
Lack of Assurance of Sterility.