Leiter's Compounding

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0014-2017Class IILidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total VolSeptember 20, 2016
D-0011-2017Class IIBrilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (PreserSeptember 20, 2016
D-0017-2017Class IIPlacebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's CoSeptember 20, 2016
D-0012-2017Class IICefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (PrSeptember 20, 2016
D-0010-2017Class IIAtropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL September 20, 2016
D-0013-2017Class IICyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (OphtSeptember 20, 2016
D-0018-2017Class IIVancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (PreservatSeptember 20, 2016
D-0016-2017Class IIMoxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total VolSeptember 20, 2016
D-0015-2017Class IIMitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL September 20, 2016