Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., L...
FDA Recall #D-0278-2025 — Class II — March 7, 2025
Product Description
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
Reason for Recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Recalling Firm
Slate Run Pharmaceuticals — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
56,790 bottles
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Code Information
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated