Drug product
C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
D-0033-2020
Product summary
- Event
- Event 83427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 vials
- Official record key
drug-enforcement:D-0033-2020
Official wording
Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Code information: Lot #: 062719A, BUD 08/11/19
Distribution pattern: Patient Specific Prescriptions in NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility