FDA recall D-0278-2025

Slate Run Pharmaceuticals · Class II · drug

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-03-07
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0278-2025