FDARecalled Mar 26, 2025 · #D-0279-2025
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
Hazard
Class II — temporary health risk
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CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Classification: Class II Distribution: Product was distributed to 8 distributors who may have further distribute the product nationwide.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Slate Run Pharmaceuticals
- Model numbers
- 109797
- UPCs
- —