Lohxa LLC

FDA Regulatory Profile

Summary

Total Recalls
4 (2 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0377-2022Class ISENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARDecember 21, 2021
D-0111-2021Class IChlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcoOctober 28, 2020
D-1130-2019Class IIBismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MMarch 25, 2019
D-1131-2019Class IIPhenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 016March 25, 2019