Multi event Drug Recall Enforcement Report Class II voluntary initiated by Slate Run Pharmaceuticals, originally initiated on 03-07-2025 for the 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 The product was recalled due to cgmp deviations: the presence of nitrosamine impurity above the acceptable daily intake limits.. 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-0279-2025 | 03-07-2025 | 03-26-2025 | Class II | 2,444 bottles | 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 | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Ongoing |
| D-0278-2025 | 03-07-2025 | 03-26-2025 | Class II | 56,790 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 | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Ongoing |
Recalled Products
