Drug product
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
D-0748-2018
Product summary
- Event
- Event 79748
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0748-2018
Official wording
Reason: Lack of Processing Controls.
Code information: All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Distribution pattern: MS, LA, AR, IL, FL
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls