Specialty Compounding, LLC

FDA Regulatory Profile

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0230-2015Class ICALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only August 9, 2013
D-0231-2015Class IIAll products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613August 9, 2013