Drug product
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
D-0732-2018
Product summary
- Event
- Event 80000
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0732-2018
Official wording
Reason: 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.
Code information: Lot #: 03052018@54
Distribution pattern: The recalled product was distributed to patients throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility