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 for recall: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Recall initiated: 20250307
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated