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Northern VA Compounders PLLC

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
0
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0110-2023Class IIProstaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded byDecember 30, 2022
D-0120-2023Class IIQuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJEDecember 30, 2022
D-0103-2023Class IIQuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLEDecember 30, 2022
D-0126-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged December 30, 2022
D-0121-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mDecember 30, 2022
D-0109-2023Class IIProstaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, CDecember 30, 2022
D-0112-2023Class IIProstaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by:December 30, 2022
D-0114-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL MuDecember 30, 2022
D-0125-2023Class IIBiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose viDecember 30, 2022
D-0102-2023Class IIMitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded byDecember 30, 2022
D-0123-2023Class IITriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged December 30, 2022
D-0122-2023Class IIBiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL December 30, 2022
D-0115-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL MuDecember 30, 2022
D-0117-2023Class IITriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL MulDecember 30, 2022
D-0118-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaDecember 30, 2022
D-0116-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL MDecember 30, 2022
D-0106-2023Class IITriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packagDecember 30, 2022
D-0111-2023Class IIProstaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by:December 30, 2022
D-0113-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL MuDecember 30, 2022
D-0105-2023Class IIQuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECDecember 30, 2022