FDA recall D-0028-2025

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

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
2024-10-09
Report date
2024-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0028-2025