Pine Pharmaceuticals, LLC

FDA Regulatory Profile

Summary

Total Recalls
24
510(k) Clearances
0
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0060-2024Class IITPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppOctober 2, 2023
D-0056-2024Class IIMoxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0October 2, 2023
D-0052-2024Class IIEndophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine PharmaOctober 2, 2023
D-0050-2024Class IIBevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine PharmOctober 2, 2023
D-0058-2024Class IIMoxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, CompoOctober 2, 2023
D-0053-2024Class IICalcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine PharmOctober 2, 2023
D-0065-2024Class IIFoscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip SyringeOctober 2, 2023
D-0054-2024Class IICalcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by PineOctober 2, 2023
D-0059-2024Class IILidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 35October 2, 2023
D-0055-2024Class IITropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, RxOctober 2, 2023
D-0061-2024Class IICalcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by POctober 2, 2023
D-0051-2024Class IIVancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, CompounOctober 2, 2023
D-0064-2024Class IILidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes,October 2, 2023
D-0057-2024Class IICefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 RivOctober 2, 2023
D-0062-2024Class IILidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine PharmaceuOctober 2, 2023
D-0063-2024Class IITropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only,October 2, 2023
D-0531-2023Class IIIBevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each SyrinMarch 27, 2023
D-0130-2023Class IIEpi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single DDecember 22, 2022
D-1514-2022Class IIBupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar InjectionJuly 27, 2022
D-0607-2018Class IIIBrilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine PharmaceuticalMarch 5, 2018