Drug product
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
D-0023-2020
Product summary
- Event
- Event 83427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0023-2020
Official wording
Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Code information: Lot #: 062719E, BUD 08/11/19
Distribution pattern: Patient Specific Prescriptions in NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility