Slate Run Pharmaceuticals

FDA Regulatory Profile

Slate Run Pharmaceuticals appears in FDA public data with 3 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-0343-2026, Class III) was initiated on February 12, 2026.

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-0278-2025Class IICinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC,March 7, 2025
D-0279-2025Class IICinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC,March 7, 2025