FDA DrugsClass II
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: ...
Published: July 1, 2026Recall ID: D-0614-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
Additional Source Details
| Field | Value |
|---|---|
| City | Thousand Oaks |
| State | CA |
| Openfda › Unii | 1K860WSG25 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 432400 |
| Openfda › Rxcui › 2 | 432401 |
| Openfda › Rxcui › 3 | 432402 |
| Openfda › Rxcui › 4 | 656137 |
| Openfda › Rxcui › 5 | 706958 |
| Openfda › Rxcui › 6 | 706960 |
| Openfda › Spl id | 42c2c9c2-6929-4952-b559-a57a1d75424e |
| Openfda › Brand name | SENSIPAR |
| Openfda › Spl set id | 45028573-13c4-4c8b-ae62-6c75bba97c81 |
| Openfda › Package ndc › 1 | 55513-073-30 |
| Openfda › Package ndc › 2 | 55513-074-30 |
| Openfda › Package ndc › 3 | 55513-075-30 |
| Openfda › Product ndc › 1 | 55513-073 |
| Openfda › Product ndc › 2 | 55513-074 |
| Openfda › Product ndc › 3 | 55513-075 |
| Openfda › Generic name | CINACALCET HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | CINACALCET HYDROCHLORIDE |
| Openfda › Manufacturer name | Amgen Inc |
| Openfda › Application number | NDA021688 |
| Openfda › Is original packager | true |
| Event id | 99077 |
| Address 1 | 1 Amgen Center Dr |
| Address 2 | N/A |
| Code info | Lot #: 1157055, Exp. Date 1/31/2028 |
| Postal code | 91320-1730 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | CGMP Deviations |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Letter |
| Center classification date | 20260623 |
Overview
- Recalling FirmAmgen, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States