Drug product
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
D-0616-2026
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 99077
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0616-2026
Official wording
Reason: CGMP Deviations
Code information: Lot #: 1157056, Exp. Date 02/29/2028
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations