FDA recall D-0077-2025

Product

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.

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2024-11-07

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2025