Recalling firm
Slate Run Pharmaceuticals
Product type
Drug
Status
Completed
Report date
2025-03-26
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Firm state
OH
Product quantity
2,444 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Product description
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
Code / lot info
Lot # 109797, Exp 11/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.