Drug product
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
D-0736-2018
Product summary
- Event
- Event 79748
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0736-2018
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