D-0028-2025 Class II Ongoing
FDA drug recall D-0028-2025 was initiated by Dr. Reddy's Laboratories, Inc. on October 9, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit The recall status is ongoing. Affected quantity: 10584 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2024
- Initiation Date
- October 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10584 bottles
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.
Reason for Recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Distribution Pattern
USA Nationwide.
Code Information
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.