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D-0278-2025Class II

Slate Run Pharmaceuticals

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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
56,790 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Product description

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

Code / lot info

Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. 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. Open the enforcement explorer →