Recalls / Class II
Class IID-0279-2025
Product
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
- Affected lot / code info
- Lot # 109797, Exp 11/2026
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
- 2,444 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-0279-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.