FDA-Drug2025-03-26Class II
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
Hazard
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Sold states
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Affected count
2,444 bottles
Manufactured in
277 W Nationwide Blvd Ste 260, N/A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0279-2025Don't want to check this manually?
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