Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Recall Number: D-0028-2025
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class II
Status: Ongoing
Report Date: 20241106
Initiation Date: 20241009
Termination Date:
Reason for Recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product Description
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.