Class II · Moderate risk
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Lack of sterility assurance.
FDA Drug Recalls
343 recalls, newest first
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.
Class II · Moderate risk
NEOstigmine Methylsulfate
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Testosterone/Finasteride 80 mg/8 mg pellet
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 55 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 50 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 40 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 35 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 25 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 20 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 15 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 12.5 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 10 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.