FDA Recall D-0278-2025

Slate Run Pharmaceuticals · Columbus, OH

Class II Ongoing 433 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 56,790 bottles

Reason for recall

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

Recall record

Recall number: D-0278-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed to 8 distributors who may have further distribute the product nationwide.
Recall initiated: 2025-03-07
Classified by FDA Center: 2025-03-17
FDA published: 2025-03-26
Recalling firm: Slate Run Pharmaceuticals
Firm location: Columbus, OH

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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