Recall: D-0028-2025

Class II - Potentially Harmful

Class IIClassification

2024-10-09Initiated

OngoingStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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

Distribution

USA Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.