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
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Fluconazole Injection
Cross contamination with other products: metronidazole
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Thyrogen (thyrotropin alfa for injection)
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk
Thyrogen (thyrotropin alfa for injection)
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk
Paliperidone Extended-release Tablets
Failed Dissolution Specifications; three month stability time point.
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
Alendronate Sodium Tablets
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
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
Medicated Better Braids
Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.