D-0613-2026 Class II Ongoing
FDA drug recall D-0613-2026 was initiated by Amgen, Inc. on June 4, 2026 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 9565 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- June 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9565 bottles
Product Description
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
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot#: 1156858, Exp. Date 12/31/2027.