Slate Run Pharmaceuticals: Drug Recall
Recall #D-0278-2025 · 03/07/2025
Class II: Risk
Recall Details
- Recall Number
- D-0278-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Slate Run Pharmaceuticals
- Status
- Ongoing
- Date Initiated
- 03/07/2025
- Location
- Columbus, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,790 bottles
Reason for Recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Product Description
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
Distribution Pattern
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Other Recalls by Slate Run Pharmaceuticals
- Class II: Risk 03/07/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.