Class II · Moderate risk
Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag
Lack of Sterility Assurance.
FDA Drug Recalls
635 recalls, newest first
Class II · Moderate risk
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe
Lack of Sterility Assurance
Class II · Moderate risk
Deferoxamine 4 grams/NS 101 mL Cassette
Lack of Sterility Assurance
Class II · Moderate risk
Deferoxamine 2 grams/51 mL NS cassette
Lack of Sterility Assurance.
Class II · Moderate risk
Daptomycin 650 mg in 50 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
D5 1/2 NS 1000 mL with Electrolytes bag
Lack of Sterility Assurance
Class II · Moderate risk
Clindamycin 900 mg in 100 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 2 gram in 100 mL 0.9% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Cefazolin 6 grams in 292 mL 0.9% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Ascorbic Acid 500 mg
Lack of Sterility Assurance
Class II · Moderate risk
70% Ethanol-lock Solution
Lack of Sterility Assurance
Class II · Moderate risk
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq.
Lack of Sterility Assurance.
Class II · Moderate risk
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags
Lack of Sterility Assurance
Class I · High risk
5% Dextrose Injection USP
Non-Sterility: fungal contamination due to leaking containers.
Class II · Moderate risk
Formula 0 (PGE 20 mcg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 9
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Zoledronic Acid Injection
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II · Moderate risk
Tobramycin 14 mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 50mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine Nebulizer 1% Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium 2% Ophth Solution
Lack of Assurance of Sterility