Axcentria Pharmaceuticals LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2069-2014Class IICalcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product June 5, 2014
D-1434-2014Class IIHemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, PitMay 5, 2014
D-134-2013Class IIIMajor Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major PharmaceuticalsAugust 17, 2012
D-1441-2012Class IIIMajor brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, July 12, 2012