Drug product
C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
D-0014-2020
Product summary
- Event
- Event 83427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 vials
- Official record key
drug-enforcement:D-0014-2020
Official wording
Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Code information: Lot #: 041119A, BUD 10/08/19; 051019J, BUD 11/6/19; 070519C, BUD 01/01/20
Distribution pattern: Patient Specific Prescriptions in NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility