Slate Run Pharmaceuticals

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0343-2026Class IIIEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose ViaFebruary 12, 2026
D-0279-2025Class IICinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC,March 7, 2025
D-0278-2025Class IICinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC,March 7, 2025