Home / Recalls / Slate Run Pharmaceuticals / D-0278-2025

D-0278-2025 Class II Ongoing

Recalled by Slate Run Pharmaceuticals — Columbus, OH

Recall Details

Product Type: Drugs
Report Date: March 26, 2025
Initiation Date: March 7, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56,790 bottles

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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