MedicineWatch US
Class II Recall

Slate Run Pharmaceuticals

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
Reason
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Classification
Class II
Status
Completed
Lot
Lot # 109797, Exp 11/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Slate Run Pharmaceuticals — Class II Recall | MedicineWatch US