Cinacalcet Tablets recalled over manufacturing violations

Recall date

November 7, 2024

Source

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

Official notice title

Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862…

Recall number

D-0077-2025

FDA classification

Class II

Brand / firm

Aurobindo Pharma USA Inc

Sold / distributed

USA Nationwide

Why it was recalled

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

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 Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.