Drug product
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
D-0279-2025
Product summary
- Event
- Event 96433
- Status
- Completed
- Classification
- Class II
- Quantity
- 2,444 bottles
- Official record key
drug-enforcement:D-0279-2025
Official wording
Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Code information: Lot # 109797, Exp 11/2026
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