CINACALCET HYDROCHLORIDE
Wed Mar 26 2025
1 of 8
Summary
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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 | Slate Run Pharmaceuticals | Product was distributed to 8 distributors who may have further distribute the product nationwide. | 2,444 bottles |
| 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 | Slate Run Pharmaceuticals | Product was distributed to 8 distributors who may have further distribute the product nationwide. | 56,790 bottles |