Class II · Moderate risk
Formula 9
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Superpotent Drug: one ingredient was found to be above assay specification.
Class II · Moderate risk
Potassium Chloride Injection 20 mEq
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Mannitol I.V.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Aminosyn-PF
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
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
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