Class II

Drug Recall: 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 · March 7, 2025

Reason for Recall

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Distribution

Product was distributed to 8 distributors who may have further distribute the product nationwide.

States Affected

NATIONWIDE

Quantity Affected

2,444 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0279-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.