Slate Run Pharmaceuticals recalls Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 4321
Recalled March 26, 2025 · FDA recall D-0278-2025 · Slate Run Pharmaceuticals
Hazard
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. · FDA Class II
Units
56,790 bottles
Sold at
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Description
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Product
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
Manufacturer(s)
Slate Run Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →