Drug product
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
D-0613-2026
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 99077
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9565 bottles
- Official record key
drug-enforcement:D-0613-2026
Official wording
Reason: CGMP Deviations
Code information: Lot#: 1156858, Exp. Date 12/31/2027.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations