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
Reported: March 26, 2025 Initiated: March 7, 2025 #D-0279-2025
Product Description
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
Reason for Recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Details
- Recalling Firm
- Slate Run Pharmaceuticals
- Units Affected
- 2,444 bottles
- Distribution
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Slate Run Pharmaceuticals. Units affected: 2,444 bottles.
Why was this product recalled? ▼
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 26, 2025. Severity: Moderate. Recall number: D-0279-2025.
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