US Specialty Formulations LLC

FDA Regulatory Profile

US Specialty Formulations LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 7 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0986-2022, Class II) was initiated on May 24, 2022.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
7
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0986-2022Class IIEthanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South AlbMay 24, 2022
D-0987-2022Class IIB-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, TMay 24, 2022