Product: Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
Reason for recall: 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.
Recall initiated: 20180424
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated