Cinacalcet Hydrochloride Tablets 60 mg recalled over manufacturing violations

Recall date

March 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Slate Run Pharmaceuticals recalls Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 432…

Recall number

D-0279-2025

FDA classification

Class II

Brand / firm

Slate Run Pharmaceuticals

Sold / distributed

Product was distributed to 8 distributors who may have further distribute the product nationwide.

Why it was recalled

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04