Class II · Moderate risk
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Midazolam HCL 100 mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydromorphone HCl 10 mg
Lack of Assurance of Sterility.
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.