Recalls / Class II

Class IID-0278-2025

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Slate Run Pharmaceuticals

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

277 W Nationwide Blvd Ste 260, N/A, Columbus, Ohio 43215-0169

Distribution

Quantity

56,790 bottles

Distribution pattern

Product was distributed to 8 distributors who may have further distribute the product nationwide.

Timeline

Recall initiated

2025-03-07

FDA classified

2025-03-17

Posted by FDA

2025-03-26

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0278-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.