FDAFDA · Food and drugs·Recall number 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
Published March 26, 2025 · Recall initiated: March 7, 2025
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Slate Run Pharmaceuticals
- Distributor
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Lot
- Lot # 109797, Exp 11/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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