Sensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations
Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source identifies this as an FDA Class II recall for CGMP deviations. The source text contains no reports of illness, injury, or hospitalization related to this manufacturing deviation, and the hazard is theoretical rather than confirmed.
Plain-English summary
Amgen, Inc. is voluntarily recalling Sensipar (cinacalcet hydrochloride) Tablets, 30mg, in 30-count bottles. The recall affects 9,565 bottles distributed nationwide within the United States. The specific affected lot is Lot #1156858 with an expiration date of 12/31/2027, NDC 55513-073-30.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Sensipar is a prescription medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease.
Patients currently taking Sensipar from the recalled lot should contact their healthcare provider or pharmacist immediately. Do not stop taking the medication without medical guidance, as discontinuation without professional advice may affect treatment. Healthcare providers and patients can contact Amgen, Inc. at One Amgen Center Drive, Thousand Oaks, California 91320-1799 for additional information about the recall.
The recalled product
- Product
- SENSIPAR (CINACALCET HYDROCHLORIDE)
- Brand
- SENSIPAR
- Manufacturer
- Amgen, Inc.
- Hazard
- cgmp-deviation
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 1156858
- Exp. Date 12/31/2027.
Distribution
Distributed nationwide across the United States.
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