Drug product
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
D-0729-2018
Product summary
- Event
- Event 80000
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 vials
- Official record key
drug-enforcement:D-0729-2018
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 #: 02122018@77, Exp 05/13/2018
Distribution pattern: The recalled product was distributed to patients throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility