Class I · High risk Terminated
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per…
Reason Presence of Particulate Matter: identified as glass.
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Class I · High risk Terminated
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per…
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and…
Reason Presence of Particulate Matter: identified as glass.
Class II · Moderate risk Terminated
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Reason Microbial contamination of Non-Sterile Products
Class II · Moderate risk Terminated
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Reason Microbial contamination of Non-Sterile Products
Class I · High risk Terminated
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Reason Microbial contamination of Non-Sterile Products
Class II · Moderate risk Ongoing
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled…
Reason Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required…
Class II · Moderate risk Ongoing
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For…
Reason Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5…
Class I · High risk Completed
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey…
Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial…