Drug recall D-0279-2025

Class II Completed reported Mar 26, 2025

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.

Lots and codes

Lot # 109797, Exp 11/2026

Recall details

Recalling firm
Slate Run Pharmaceuticals, Columbus, OH
Quantity
2,444 bottles
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Type
Voluntary: Firm initiated
Recall initiated
March 7, 2025