Class II · Moderate risk
70% Ethanol-lock Solution
Lack of Sterility Assurance
FDA Drug Recalls
6,161 recalls · Class II, newest first
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 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
Class II · Moderate risk
Acetylcysteine 10% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Atropine 0.01% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 25mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin 15mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Silver Nitrate 1% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Rose Bengal 1% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine Nebulizer 2% Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium 3% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Cefazolin 50 mg/mL Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
TEARS Naturale FREE
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
Class II · Moderate risk
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 0.5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 0.5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 20 mg/ml
Lack of Assurance of Sterility