Class II · Moderate risk
Edetate Disodium 3% Ophth Solution
Lack of Assurance of Sterility
FDA Drug Recalls
966 recalls · Class II, newest first
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.
Class II · Moderate risk
Tudorza Pressair
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Class II · Moderate risk
Paricalcitol Capsules
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
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
Class II · Moderate risk
Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 11 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 1 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL…
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 1.5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 2 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 25 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml
Lack of Assurance of Sterility