Northern VA Compounders PLLC

FDA Regulatory Profile

Northern VA Compounders PLLC appears in FDA public data with 25 recalls, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0103-2023, Class II) was initiated on December 30, 2022.

Summary

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

Recent Recalls

NumberClassProductDate
D-0103-2023Class IIQuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLEDecember 30, 2022
D-0121-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mDecember 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-0102-2023Class IIMitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded byDecember 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-0116-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL MDecember 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-0117-2023Class IITriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL MulDecember 30, 2022
D-0106-2023Class IITriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packagDecember 30, 2022
D-0113-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL MuDecember 30, 2022
D-0108-2023Class IIQuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECDecember 30, 2022
D-0126-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged 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-0123-2023Class IITriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged December 30, 2022
D-0105-2023Class IIQuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECDecember 30, 2022
D-0104-2023Class IIQuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INDecember 30, 2022
D-0118-2023Class IITriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaDecember 30, 2022
D-0107-2023Class IIQuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INDecember 30, 2022
D-0119-2023Class IIMethylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, CompouDecember 30, 2022