Leiter's Compounding

FDA Drug Class II Terminated

Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-01

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 703

September 20, 2016 Leiter's Compounding 76,315 total units, all products units

FDA Drug Class II Terminated

Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units