Multi event Drug Recall Enforcement Report Class II voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 10-09-2024 for the 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. The product was recalled due to cgmp deviations: presence of n-nitroso cinacalcet impurity above fda recommended interim limit. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0028-2025 | 10-09-2024 | 11-06-2024 | Class II | 10584 bottles | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Ongoing |
| D-0027-2025 | 10-09-2024 | 11-06-2024 | Class II | 35880 bottles | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Ongoing |
| D-0026-2025 | 10-09-2024 | 11-06-2024 | Class II | 285126 bottles | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Ongoing |
Recalled Products
