Class II
Ongoing
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
This recall is currently active, issued March 26, 2025. It was issued by Slate Run Pharmaceuticals.
- Company
- Slate Run Pharmaceuticals
- Recall Initiated
- March 7, 2025
- Posted
- March 26, 2025
- Recall Number
- D-0279-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,444 bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Lot / Code Info
Lot # 109797, Exp 11/2026
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