Class III · Low risk Terminated
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health…
Reason Labeling: Not Elsewhere Classified
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Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not…
Reason Subpotent: Failing Test Results for Epinephrine
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.
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