FDAHealthMarch 7, 2025
Slate Run Pharmaceuticals — 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,
⚠️ CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 7, 2025
Product was distributed to 8 distributors who may have further distribute the product nationwide.
What's affected?
- 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
- 07711
Additional details
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 56,790 bottles.
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