Class II · Moderate risk
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Lack of sterility assurance.
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL…
Lack of sterility assurance.
Class II · Moderate risk
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL…
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 200 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials…
Lack of sterility assurance.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV…
Lack of sterility assurance.
Class II · Moderate risk
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled…
Lack of sterility assurance.
Class II · Moderate risk
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial…
Lack of sterility assurance.
Class II · Moderate risk
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml…
Lack of sterility assurance.
Class II · Moderate risk
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100…
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Lack of sterility assurance.
Class II · Moderate risk
Macroaggregated albumin
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Alprostadil 20 mcg/mL
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class II · Moderate risk
Methylcobalamin for injection
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.