Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk Terminated
Thyrogen
Reason Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk Terminated
Thyrogen
Reason Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk Terminated
Paliperidone Extended-release Tablets
Reason Failed Dissolution Specifications; three month stability time point.
Class II · Moderate risk Terminated
Tobramycin 14 mg/mL Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 50mg/mL Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine Nebulizer 1% Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Edetate Disodium 2% Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Acetylcysteine 10% Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Atropine 0.01% Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 25mg/mL Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tobramycin 15mg/mL Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Silver Nitrate 1% Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Rose Bengal 1% Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine Nebulizer 2% Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Edetate Disodium 3% Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefazolin 50 mg/mL Ophth Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alendronate Sodium Tablets
Reason Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Class II · Moderate risk Terminated
TEARS Naturale FREE
Reason 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 Terminated
Medicated Better Braids
Reason Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
Class II · Moderate risk Terminated
Tudorza Pressair
Reason Defective Delivery System: Some units have actuation counters set to a number other than 60.
Class II · Moderate risk Terminated
Paricalcitol Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation
Reason PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.