Drug product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
D-0278-2025
Product summary
- Event
- Event 96433
- Status
- Completed
- Classification
- Class II
- Quantity
- 56,790 bottles
- Official record key
drug-enforcement:D-0278-2025
Official wording
Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Code information: Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Distribution pattern: Product was distributed to 8 distributors who may have further distribute the product nationwide.
Derived failure modes
-
Foreign material or chemical contamination
nitrosamine impurity
-
Manufacturing or process control
CGMP deviations