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Pine Pharmaceuticals, LLC FDA Recalls
19 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine PharmacClass IIOct 2, 2023Lack of Assurance of Sterility |
| Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, TonaClass IIOct 2, 2023Lack of Assurance of Sterility |
| Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals Class IIOct 2, 2023Lack of Assurance of Sterility |
| Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx onClass IIOct 2, 2023Lack of Assurance of Sterility |
| Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine PharmClass IIOct 2, 2023Lack of Assurance of Sterility |
| TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, CompouClass IIOct 2, 2023Lack of Assurance of Sterility |
| Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Class IIOct 2, 2023Lack of Assurance of Sterility |
| Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 RiverClass IIOct 2, 2023Lack of Assurance of Sterility |
| Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, CompoundeClass IIOct 2, 2023Lack of Assurance of Sterility |
| Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded byClass IIOct 2, 2023Lack of Assurance of Sterility |
| Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 RiverwalkClass IIOct 2, 2023Lack of Assurance of Sterility |
| Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355Class IIOct 2, 2023Lack of Assurance of Sterility |
| Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 RiverwClass IIOct 2, 2023Lack of Assurance of Sterility |
| Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 RiverClass IIOct 2, 2023Lack of Assurance of Sterility |
| Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, CompoundedClass IIOct 2, 2023Lack of Assurance of Sterility |
| Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway,Class IIOct 2, 2023Lack of Assurance of Sterility |
| Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in indivClass IIIMar 27, 2023Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code |
| Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, CompoundedClass IIDec 22, 2022CGMP Deviations: Raw material recalled by repackager, due to |
| Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 Class IIJul 27, 2022Lack of Assurance of Sterility |